List of Excipients in API dabigatran etexilate
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Excipients in NDA-approved (novel) drugs containing dabigatran etexilate
| Company | Tradename | Ingredient | NDC | Excipient | Potential Generic Entry |
|---|---|---|---|---|---|
| Boehringer Ingelheim Pharmaceuticals Inc | PRADAXA | dabigatran etexilate | 0597-0425 | ACACIA | |
| Boehringer Ingelheim Pharmaceuticals Inc | PRADAXA | dabigatran etexilate | 0597-0425 | DIMETHICONE | |
| Boehringer Ingelheim Pharmaceuticals Inc | PRADAXA | dabigatran etexilate | 0597-0425 | HYDROXYPROPYL CELLULOSE | |
| Boehringer Ingelheim Pharmaceuticals Inc | PRADAXA | dabigatran etexilate | 0597-0425 | HYPROMELLOSE | |
| Boehringer Ingelheim Pharmaceuticals Inc | PRADAXA | dabigatran etexilate | 0597-0425 | TALC | |
| Boehringer Ingelheim Pharmaceuticals Inc | PRADAXA | dabigatran etexilate | 0597-0425 | TARTARIC ACID | |
| Rebel Distributors Corp | PRADAXA | dabigatran etexilate mesylate | 21695-899 | ACACIA | |
| >Company | >Tradename | >Ingredient | >NDC | >Excipient | >Potential Generic Entry |
Excipients in ANDA-approved (generic) drugs containing dabigatran etexilate
Detailed excipient profiles for dabigatran etexilate
Excipient focus: ACACIA
dabigatran etexilate drug variants containing ACACIA
| Company | Ingredient | NDC |
|---|---|---|
| Boehringer Ingelheim Pharmaceuticals Inc | dabigatran etexilate | 0597-0425 |
| DrReddys Laboratories Inc | dabigatran etexilate | 43598-642 |
| Rebel Distributors Corp | dabigatran etexilate mesylate | 21695-899 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing ACACIA
Excipient focus: ALCOHOL
dabigatran etexilate drug variants containing ALCOHOL
| Company | Ingredient | NDC |
|---|---|---|
| Rebel Distributors Corp | dabigatran etexilate mesylate | 21695-899 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing ALCOHOL
Excipient focus: AMMONIA
dabigatran etexilate drug variants containing AMMONIA
dabigatran etexilate drug variants not containing AMMONIA
Excipient focus: BUTYL ALCOHOL
dabigatran etexilate drug variants containing BUTYL ALCOHOL
| Company | Ingredient | NDC |
|---|---|---|
| DrReddys Laboratories Inc | dabigatran etexilate | 43598-642 |
| Rebel Distributors Corp | dabigatran etexilate mesylate | 21695-899 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing BUTYL ALCOHOL
Excipient focus: BUTYLATED HYDROXYTOLUENE
dabigatran etexilate drug variants containing BUTYLATED HYDROXYTOLUENE
| Company | Ingredient | NDC |
|---|---|---|
| Major Pharmaceuticals | dabigatran etexilate | 0904-7253 |
| A-S Medication Solutions | dabigatran etexilate | 50090-7656 |
| A-S Medication Solutions | dabigatran etexilate | 50090-7657 |
| Ascend Laboratories LLC | dabigatran etexilate | 67877-475 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing BUTYLATED HYDROXYTOLUENE
Excipient focus: CARRAGEENAN
dabigatran etexilate drug variants containing CARRAGEENAN
dabigatran etexilate drug variants not containing CARRAGEENAN
Excipient focus: CELLULOSE, MICROCRYSTALLINE
dabigatran etexilate drug variants containing CELLULOSE, MICROCRYSTALLINE
dabigatran etexilate drug variants not containing CELLULOSE, MICROCRYSTALLINE
Excipient focus: CITRIC ACID
dabigatran etexilate drug variants containing CITRIC ACID
| Company | Ingredient | NDC |
|---|---|---|
| A-S Medication Solutions | dabigatran etexilate | 50090-7656 |
| A-S Medication Solutions | dabigatran etexilate | 50090-7657 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing CITRIC ACID
Excipient focus: CITRIC ACID MONOHYDRATE
dabigatran etexilate drug variants containing CITRIC ACID MONOHYDRATE
| Company | Ingredient | NDC |
|---|---|---|
| Major Pharmaceuticals | dabigatran etexilate | 0904-7253 |
| Ascend Laboratories LLC | dabigatran etexilate | 67877-475 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing CITRIC ACID MONOHYDRATE
Excipient focus: CROSCARMELLOSE SODIUM
dabigatran etexilate drug variants containing CROSCARMELLOSE SODIUM
dabigatran etexilate drug variants not containing CROSCARMELLOSE SODIUM
Excipient focus: CROSPOVIDONE
dabigatran etexilate drug variants containing CROSPOVIDONE
| Company | Ingredient | NDC |
|---|---|---|
| Mylan Pharmaceuticals Inc | dabigatran etexilate | 0378-0265 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing CROSPOVIDONE
Excipient focus: CURRY RED
dabigatran etexilate drug variants containing CURRY RED
| Company | Ingredient | NDC |
|---|---|---|
| A-S Medication Solutions | dabigatran etexilate | 50090-7657 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing CURRY RED
Excipient focus: DEHYDRATED ALCOHOL
dabigatran etexilate drug variants containing DEHYDRATED ALCOHOL
| Company | Ingredient | NDC |
|---|---|---|
| DrReddys Laboratories Inc | dabigatran etexilate | 43598-642 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing DEHYDRATED ALCOHOL
Excipient focus: DIMETHICONE
dabigatran etexilate drug variants containing DIMETHICONE
| Company | Ingredient | NDC |
|---|---|---|
| Boehringer Ingelheim Pharmaceuticals Inc | dabigatran etexilate | 0597-0425 |
| DrReddys Laboratories Inc | dabigatran etexilate | 43598-642 |
| Rebel Distributors Corp | dabigatran etexilate mesylate | 21695-899 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing DIMETHICONE
Excipient focus: ETHYLCELLULOSE
dabigatran etexilate drug variants containing ETHYLCELLULOSE
| Company | Ingredient | NDC |
|---|---|---|
| Aurobindo Pharma Limited | dabigatran etexilate | 59651-973 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing ETHYLCELLULOSE
Excipient focus: FD&C BLUE NO. 1
dabigatran etexilate drug variants containing FD&C BLUE NO. 1
| Company | Ingredient | NDC |
|---|---|---|
| A-S Medication Solutions | dabigatran etexilate | 50090-7657 |
| Apotex Corp | dabigatran etexilate | 60505-4347 |
| Ascend Laboratories LLC | dabigatran etexilate | 67877-475 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing FD&C BLUE NO. 1
Excipient focus: FD&C BLUE NO. 2
dabigatran etexilate drug variants containing FD&C BLUE NO. 2
| Company | Ingredient | NDC |
|---|---|---|
| Rebel Distributors Corp | dabigatran etexilate mesylate | 21695-899 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing FD&C BLUE NO. 2
Excipient focus: FD&C RED NO. 40
dabigatran etexilate drug variants containing FD&C RED NO. 40
| Company | Ingredient | NDC |
|---|---|---|
| Ascend Laboratories LLC | dabigatran etexilate | 67877-475 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing FD&C RED NO. 40
Excipient focus: FD&C YELLOW NO. 6
dabigatran etexilate drug variants containing FD&C YELLOW NO. 6
| Company | Ingredient | NDC |
|---|---|---|
| Major Pharmaceuticals | dabigatran etexilate | 0904-7253 |
| Aurobindo Pharma Limited | dabigatran etexilate | 59651-973 |
| Ascend Laboratories LLC | dabigatran etexilate | 67877-475 |
| Rebel Distributors Corp | dabigatran etexilate mesylate | 21695-899 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing FD&C YELLOW NO. 6
Excipient focus: FERRIC OXIDE RED
dabigatran etexilate drug variants containing FERRIC OXIDE RED
| Company | Ingredient | NDC |
|---|---|---|
| Camber Pharmaceuticals Inc | dabigatran etexilate | 31722-621 |
| Apotex Corp | dabigatran etexilate | 60505-4347 |
| American Health Packaging | dabigatran etexilate | 60687-744 |
| XLCare Pharmaceuticals Inc | dabigatran etexilate | 72865-272 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing FERRIC OXIDE RED
Excipient focus: FERRIC OXIDE YELLOW
dabigatran etexilate drug variants containing FERRIC OXIDE YELLOW
| Company | Ingredient | NDC |
|---|---|---|
| Camber Pharmaceuticals Inc | dabigatran etexilate | 31722-621 |
| Apotex Corp | dabigatran etexilate | 60505-4347 |
| American Health Packaging | dabigatran etexilate | 60687-744 |
| XLCare Pharmaceuticals Inc | dabigatran etexilate | 72865-272 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing FERRIC OXIDE YELLOW
Excipient focus: FERROSOFERRIC OXIDE
dabigatran etexilate drug variants containing FERROSOFERRIC OXIDE
dabigatran etexilate drug variants not containing FERROSOFERRIC OXIDE
| Company | Ingredient | NDC |
|---|---|---|
| Boehringer Ingelheim Pharmaceuticals Inc | dabigatran etexilate | 0597-0425 |
| >Company | >Ingredient | >NDC |
Excipient focus: FUMARIC ACID
dabigatran etexilate drug variants containing FUMARIC ACID
| Company | Ingredient | NDC |
|---|---|---|
| Mylan Pharmaceuticals Inc | dabigatran etexilate | 0378-0265 |
| Apotex Corp | dabigatran etexilate | 60505-4347 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing FUMARIC ACID
Excipient focus: HYDROXYPROPYL CELLULOSE
dabigatran etexilate drug variants containing HYDROXYPROPYL CELLULOSE
dabigatran etexilate drug variants not containing HYDROXYPROPYL CELLULOSE
| Company | Ingredient | NDC |
|---|---|---|
| Aurobindo Pharma Limited | dabigatran etexilate | 59651-973 |
| Apotex Corp | dabigatran etexilate | 60505-4347 |
| >Company | >Ingredient | >NDC |
Excipient focus: HYDROXYPROPYL METHYLCELLULOSE
dabigatran etexilate drug variants containing HYDROXYPROPYL METHYLCELLULOSE
| Company | Ingredient | NDC |
|---|---|---|
| A-S Medication Solutions | dabigatran etexilate | 50090-7656 |
| A-S Medication Solutions | dabigatran etexilate | 50090-7657 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing HYDROXYPROPYL METHYLCELLULOSE
Excipient focus: HYPROMELLOSE
dabigatran etexilate drug variants containing HYPROMELLOSE
dabigatran etexilate drug variants not containing HYPROMELLOSE
Excipient focus: HYPROMELLOSE 2910
dabigatran etexilate drug variants containing HYPROMELLOSE 2910
dabigatran etexilate drug variants not containing HYPROMELLOSE 2910
Excipient focus: HYPROMELLOSE PHTHALATE
dabigatran etexilate drug variants containing HYPROMELLOSE PHTHALATE
dabigatran etexilate drug variants not containing HYPROMELLOSE PHTHALATE
Excipient focus: HYPROMELLOSES
dabigatran etexilate drug variants containing HYPROMELLOSES
| Company | Ingredient | NDC |
|---|---|---|
| DrReddys Laboratories Inc | dabigatran etexilate | 43598-642 |
| XLCare Pharmaceuticals Inc | dabigatran etexilate | 72865-272 |
| Rebel Distributors Corp | dabigatran etexilate mesylate | 21695-899 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing HYPROMELLOSES
Excipient focus: ISOPROPYL ALCOHOL
dabigatran etexilate drug variants containing ISOPROPYL ALCOHOL
| Company | Ingredient | NDC |
|---|---|---|
| Rebel Distributors Corp | dabigatran etexilate mesylate | 21695-899 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing ISOPROPYL ALCOHOL
Excipient focus: LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE
dabigatran etexilate drug variants containing LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE
| Company | Ingredient | NDC |
|---|---|---|
| Aurobindo Pharma Limited | dabigatran etexilate | 59651-973 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE
Excipient focus: MAGNESIUM STEARATE
dabigatran etexilate drug variants containing MAGNESIUM STEARATE
dabigatran etexilate drug variants not containing MAGNESIUM STEARATE
Excipient focus: MANNITOL
dabigatran etexilate drug variants containing MANNITOL
| Company | Ingredient | NDC |
|---|---|---|
| Apotex Corp | dabigatran etexilate | 60505-4347 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing MANNITOL
Excipient focus: METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
dabigatran etexilate drug variants containing METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
| Company | Ingredient | NDC |
|---|---|---|
| Major Pharmaceuticals | dabigatran etexilate | 0904-7253 |
| A-S Medication Solutions | dabigatran etexilate | 50090-7656 |
| A-S Medication Solutions | dabigatran etexilate | 50090-7657 |
| Ascend Laboratories LLC | dabigatran etexilate | 67877-475 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
Excipient focus: METHYL ALCOHOL
dabigatran etexilate drug variants containing METHYL ALCOHOL
| Company | Ingredient | NDC |
|---|---|---|
| Rebel Distributors Corp | dabigatran etexilate mesylate | 21695-899 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing METHYL ALCOHOL
Excipient focus: PEG-12
dabigatran etexilate drug variants containing PEG-12
| Company | Ingredient | NDC |
|---|---|---|
| A-S Medication Solutions | dabigatran etexilate | 50090-7656 |
| A-S Medication Solutions | dabigatran etexilate | 50090-7657 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing PEG-12
Excipient focus: POLYETHYLENE GLYCOL
dabigatran etexilate drug variants containing POLYETHYLENE GLYCOL
| Company | Ingredient | NDC |
|---|---|---|
| Major Pharmaceuticals | dabigatran etexilate | 0904-7253 |
| A-S Medication Solutions | dabigatran etexilate | 50090-7656 |
| A-S Medication Solutions | dabigatran etexilate | 50090-7657 |
| Ascend Laboratories LLC | dabigatran etexilate | 67877-475 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing POLYETHYLENE GLYCOL
Excipient focus: POLYETHYLENE GLYCOL 600
dabigatran etexilate drug variants containing POLYETHYLENE GLYCOL 600
| Company | Ingredient | NDC |
|---|---|---|
| Major Pharmaceuticals | dabigatran etexilate | 0904-7253 |
| Ascend Laboratories LLC | dabigatran etexilate | 67877-475 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing POLYETHYLENE GLYCOL 600
Excipient focus: POLYVINYL ALCOHOL
dabigatran etexilate drug variants containing POLYVINYL ALCOHOL
dabigatran etexilate drug variants not containing POLYVINYL ALCOHOL
Excipient focus: POTASSIUM CHLORIDE
dabigatran etexilate drug variants containing POTASSIUM CHLORIDE
dabigatran etexilate drug variants not containing POTASSIUM CHLORIDE
Excipient focus: POTASSIUM HYDROXIDE
dabigatran etexilate drug variants containing POTASSIUM HYDROXIDE
dabigatran etexilate drug variants not containing POTASSIUM HYDROXIDE
| Company | Ingredient | NDC |
|---|---|---|
| Boehringer Ingelheim Pharmaceuticals Inc | dabigatran etexilate | 0597-0425 |
| Rebel Distributors Corp | dabigatran etexilate mesylate | 21695-899 |
| >Company | >Ingredient | >NDC |
Excipient focus: POVIDONE K25
dabigatran etexilate drug variants containing POVIDONE K25
| Company | Ingredient | NDC |
|---|---|---|
| Major Pharmaceuticals | dabigatran etexilate | 0904-7253 |
| A-S Medication Solutions | dabigatran etexilate | 50090-7656 |
| A-S Medication Solutions | dabigatran etexilate | 50090-7657 |
| Ascend Laboratories LLC | dabigatran etexilate | 67877-475 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing POVIDONE K25
Excipient focus: PROPYLENE GLYCOL
dabigatran etexilate drug variants containing PROPYLENE GLYCOL
dabigatran etexilate drug variants not containing PROPYLENE GLYCOL
| Company | Ingredient | NDC |
|---|---|---|
| Boehringer Ingelheim Pharmaceuticals Inc | dabigatran etexilate | 0597-0425 |
| Alembic Pharmaceuticals Limited | dabigatran etexilate | 46708-634 |
| Alembic Pharmaceuticals Inc | dabigatran etexilate | 62332-634 |
| >Company | >Ingredient | >NDC |
Excipient focus: SHELLAC
dabigatran etexilate drug variants containing SHELLAC
dabigatran etexilate drug variants not containing SHELLAC
| Company | Ingredient | NDC |
|---|---|---|
| Boehringer Ingelheim Pharmaceuticals Inc | dabigatran etexilate | 0597-0425 |
| >Company | >Ingredient | >NDC |
Excipient focus: SILICON DIOXIDE
dabigatran etexilate drug variants containing SILICON DIOXIDE
| Company | Ingredient | NDC |
|---|---|---|
| Mylan Pharmaceuticals Inc | dabigatran etexilate | 0378-0265 |
| Aurobindo Pharma Limited | dabigatran etexilate | 59651-973 |
| Apotex Corp | dabigatran etexilate | 60505-4347 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing SILICON DIOXIDE
Excipient focus: SODIUM BICARBONATE
dabigatran etexilate drug variants containing SODIUM BICARBONATE
| Company | Ingredient | NDC |
|---|---|---|
| Major Pharmaceuticals | dabigatran etexilate | 0904-7253 |
| A-S Medication Solutions | dabigatran etexilate | 50090-7656 |
| A-S Medication Solutions | dabigatran etexilate | 50090-7657 |
| Ascend Laboratories LLC | dabigatran etexilate | 67877-475 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing SODIUM BICARBONATE
Excipient focus: SODIUM LAURYL SULFATE
dabigatran etexilate drug variants containing SODIUM LAURYL SULFATE
| Company | Ingredient | NDC |
|---|---|---|
| Mylan Pharmaceuticals Inc | dabigatran etexilate | 0378-0265 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing SODIUM LAURYL SULFATE
Excipient focus: SOYBEAN LECITHIN
dabigatran etexilate drug variants containing SOYBEAN LECITHIN
| Company | Ingredient | NDC |
|---|---|---|
| Aurobindo Pharma Limited | dabigatran etexilate | 59651-973 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing SOYBEAN LECITHIN
Excipient focus: STARCH, CORN
dabigatran etexilate drug variants containing STARCH, CORN
| Company | Ingredient | NDC |
|---|---|---|
| Camber Pharmaceuticals Inc | dabigatran etexilate | 31722-621 |
| American Health Packaging | dabigatran etexilate | 60687-744 |
| XLCare Pharmaceuticals Inc | dabigatran etexilate | 72865-272 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing STARCH, CORN
Excipient focus: SUCROSE
dabigatran etexilate drug variants containing SUCROSE
| Company | Ingredient | NDC |
|---|---|---|
| Camber Pharmaceuticals Inc | dabigatran etexilate | 31722-621 |
| American Health Packaging | dabigatran etexilate | 60687-744 |
| XLCare Pharmaceuticals Inc | dabigatran etexilate | 72865-272 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing SUCROSE
Excipient focus: SUNSET YELLOW
dabigatran etexilate drug variants containing SUNSET YELLOW
| Company | Ingredient | NDC |
|---|---|---|
| A-S Medication Solutions | dabigatran etexilate | 50090-7656 |
| A-S Medication Solutions | dabigatran etexilate | 50090-7657 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing SUNSET YELLOW
Excipient focus: TALC
dabigatran etexilate drug variants containing TALC
dabigatran etexilate drug variants not containing TALC
| Company | Ingredient | NDC |
|---|---|---|
| Mylan Pharmaceuticals Inc | dabigatran etexilate | 0378-0265 |
| Apotex Corp | dabigatran etexilate | 60505-4347 |
| >Company | >Ingredient | >NDC |
Excipient focus: TARTARIC ACID
dabigatran etexilate drug variants containing TARTARIC ACID
dabigatran etexilate drug variants not containing TARTARIC ACID
| Company | Ingredient | NDC |
|---|---|---|
| Mylan Pharmaceuticals Inc | dabigatran etexilate | 0378-0265 |
| Apotex Corp | dabigatran etexilate | 60505-4347 |
| >Company | >Ingredient | >NDC |
Excipient focus: TITANIUM DIOXIDE
dabigatran etexilate drug variants containing TITANIUM DIOXIDE
dabigatran etexilate drug variants not containing TITANIUM DIOXIDE
| Company | Ingredient | NDC |
|---|---|---|
| Boehringer Ingelheim Pharmaceuticals Inc | dabigatran etexilate | 0597-0425 |
| >Company | >Ingredient | >NDC |
Excipient focus: WATER
dabigatran etexilate drug variants containing WATER
| Company | Ingredient | NDC |
|---|---|---|
| Rebel Distributors Corp | dabigatran etexilate mesylate | 21695-899 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing WATER
Excipient focus: XANTHAN GUM
dabigatran etexilate drug variants containing XANTHAN GUM
| Company | Ingredient | NDC |
|---|---|---|
| Aurobindo Pharma Limited | dabigatran etexilate | 59651-973 |
| >Company | >Ingredient | >NDC |
dabigatran etexilate drug variants not containing XANTHAN GUM
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