List of Excipients in API cladribine
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Excipients in NDA-approved (novel) drugs containing cladribine
| Company | Tradename | Ingredient | NDC | Excipient | Potential Generic Entry |
|---|---|---|---|---|---|
| EMD Serono Inc | MAVENCLAD | cladribine | 44087-4000 | HYDROXYPROPYL BETADEX | |
| EMD Serono Inc | MAVENCLAD | cladribine | 44087-4000 | MAGNESIUM STEARATE | |
| EMD Serono Inc | MAVENCLAD | cladribine | 44087-4000 | SORBITOL | |
| >Company | >Tradename | >Ingredient | >NDC | >Excipient | >Potential Generic Entry |
Excipients in ANDA-approved (generic) drugs containing cladribine
| Company | Ingredient | NDC | Excipient |
|---|---|---|---|
| Hikma Pharmaceuticals USA Inc | cladribine | 0143-9871 | PHOSPHORIC ACID |
| Hikma Pharmaceuticals USA Inc | cladribine | 0143-9871 | SODIUM CHLORIDE |
| Hikma Pharmaceuticals USA Inc | cladribine | 0143-9871 | SODIUM PHOSPHATE, DIBASIC |
| Hisun Pharmaceuticals USA Inc | cladribine | 42658-010 | PHOSPHORIC ACID |
| Hisun Pharmaceuticals USA Inc | cladribine | 42658-010 | SODIUM CHLORIDE |
| >Company | >Ingredient | >NDC | >Excipient |
Detailed excipient profiles for cladribine
Excipient focus: HYDROXYPROPYL BETADEX
cladribine drug variants containing HYDROXYPROPYL BETADEX
| Company | Ingredient | NDC |
|---|---|---|
| EMD Serono Inc | cladribine | 44087-4000 |
| Apotex Corp | cladribine | 60505-4791 |
| >Company | >Ingredient | >NDC |
cladribine drug variants not containing HYDROXYPROPYL BETADEX
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | cladribine | 0143-9871 |
| Hisun Pharmaceuticals USA Inc | cladribine | 42658-010 |
| Fresenius Kabi USA LLC | cladribine | 63323-140 |
| Mylan Institutional LLC | cladribine | 67457-450 |
| >Company | >Ingredient | >NDC |
Excipient focus: MAGNESIUM STEARATE
cladribine drug variants containing MAGNESIUM STEARATE
| Company | Ingredient | NDC |
|---|---|---|
| EMD Serono Inc | cladribine | 44087-4000 |
| Apotex Corp | cladribine | 60505-4791 |
| >Company | >Ingredient | >NDC |
cladribine drug variants not containing MAGNESIUM STEARATE
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | cladribine | 0143-9871 |
| Hisun Pharmaceuticals USA Inc | cladribine | 42658-010 |
| Fresenius Kabi USA LLC | cladribine | 63323-140 |
| Mylan Institutional LLC | cladribine | 67457-450 |
| >Company | >Ingredient | >NDC |
Excipient focus: PHOSPHORIC ACID
cladribine drug variants containing PHOSPHORIC ACID
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | cladribine | 0143-9871 |
| Hisun Pharmaceuticals USA Inc | cladribine | 42658-010 |
| Fresenius Kabi USA LLC | cladribine | 63323-140 |
| Mylan Institutional LLC | cladribine | 67457-450 |
| >Company | >Ingredient | >NDC |
cladribine drug variants not containing PHOSPHORIC ACID
| Company | Ingredient | NDC |
|---|---|---|
| EMD Serono Inc | cladribine | 44087-4000 |
| Apotex Corp | cladribine | 60505-4791 |
| >Company | >Ingredient | >NDC |
Excipient focus: SODIUM CHLORIDE
cladribine drug variants containing SODIUM CHLORIDE
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | cladribine | 0143-9871 |
| Hisun Pharmaceuticals USA Inc | cladribine | 42658-010 |
| Fresenius Kabi USA LLC | cladribine | 63323-140 |
| Mylan Institutional LLC | cladribine | 67457-450 |
| >Company | >Ingredient | >NDC |
cladribine drug variants not containing SODIUM CHLORIDE
| Company | Ingredient | NDC |
|---|---|---|
| EMD Serono Inc | cladribine | 44087-4000 |
| Apotex Corp | cladribine | 60505-4791 |
| >Company | >Ingredient | >NDC |
Excipient focus: SODIUM PHOSPHATE DIBASIC DIHYDRATE
cladribine drug variants containing SODIUM PHOSPHATE DIBASIC DIHYDRATE
| Company | Ingredient | NDC |
|---|---|---|
| Hisun Pharmaceuticals USA Inc | cladribine | 42658-010 |
| >Company | >Ingredient | >NDC |
cladribine drug variants not containing SODIUM PHOSPHATE DIBASIC DIHYDRATE
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | cladribine | 0143-9871 |
| EMD Serono Inc | cladribine | 44087-4000 |
| Apotex Corp | cladribine | 60505-4791 |
| Fresenius Kabi USA LLC | cladribine | 63323-140 |
| Mylan Institutional LLC | cladribine | 67457-450 |
| >Company | >Ingredient | >NDC |
Excipient focus: SODIUM PHOSPHATE, DIBASIC
cladribine drug variants containing SODIUM PHOSPHATE, DIBASIC
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | cladribine | 0143-9871 |
| Fresenius Kabi USA LLC | cladribine | 63323-140 |
| Mylan Institutional LLC | cladribine | 67457-450 |
| >Company | >Ingredient | >NDC |
cladribine drug variants not containing SODIUM PHOSPHATE, DIBASIC
| Company | Ingredient | NDC |
|---|---|---|
| Hisun Pharmaceuticals USA Inc | cladribine | 42658-010 |
| EMD Serono Inc | cladribine | 44087-4000 |
| Apotex Corp | cladribine | 60505-4791 |
| >Company | >Ingredient | >NDC |
Excipient focus: SORBITOL
cladribine drug variants containing SORBITOL
| Company | Ingredient | NDC |
|---|---|---|
| EMD Serono Inc | cladribine | 44087-4000 |
| Apotex Corp | cladribine | 60505-4791 |
| >Company | >Ingredient | >NDC |
cladribine drug variants not containing SORBITOL
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | cladribine | 0143-9871 |
| Hisun Pharmaceuticals USA Inc | cladribine | 42658-010 |
| Fresenius Kabi USA LLC | cladribine | 63323-140 |
| Mylan Institutional LLC | cladribine | 67457-450 |
| >Company | >Ingredient | >NDC |
Excipient focus: WATER
cladribine drug variants containing WATER
| Company | Ingredient | NDC |
|---|---|---|
| Hisun Pharmaceuticals USA Inc | cladribine | 42658-010 |
| >Company | >Ingredient | >NDC |
cladribine drug variants not containing WATER
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | cladribine | 0143-9871 |
| EMD Serono Inc | cladribine | 44087-4000 |
| Apotex Corp | cladribine | 60505-4791 |
| Fresenius Kabi USA LLC | cladribine | 63323-140 |
| Mylan Institutional LLC | cladribine | 67457-450 |
| >Company | >Ingredient | >NDC |
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