List of Excipients in API tapentadol hydrochloride
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Excipients in NDA-approved (novel) drugs containing tapentadol hydrochloride
| Company | Tradename | Ingredient | NDC | Excipient | Potential Generic Entry |
|---|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc | TAPENTADOL | tapentadol hydrochloride | 0054-0936 | .ALPHA.-TOCOPHEROL | |
| Hikma Pharmaceuticals USA Inc | TAPENTADOL | tapentadol hydrochloride | 0054-0936 | FERROSOFERRIC OXIDE | |
| Hikma Pharmaceuticals USA Inc | TAPENTADOL | tapentadol hydrochloride | 0054-0936 | HYPROMELLOSE | |
| Hikma Pharmaceuticals USA Inc | TAPENTADOL | tapentadol hydrochloride | 0054-0936 | POLYETHYLENE GLYCOL | |
| >Company | >Tradename | >Ingredient | >NDC | >Excipient | >Potential Generic Entry |
Excipients in ANDA-approved (generic) drugs containing tapentadol hydrochloride
| Company | Ingredient | NDC | Excipient |
|---|---|---|---|
| EPIC PHARMA LLC | tapentadol hydrochloride | 42806-626 | CARAMEL |
| EPIC PHARMA LLC | tapentadol hydrochloride | 42806-626 | CELLULOSE, MICROCRYSTALLINE |
| EPIC PHARMA LLC | tapentadol hydrochloride | 42806-626 | COPOVIDONE K25-31 |
| EPIC PHARMA LLC | tapentadol hydrochloride | 42806-626 | CROSCARMELLOSE SODIUM |
| >Company | >Ingredient | >NDC | >Excipient |
Detailed excipient profiles for tapentadol hydrochloride
Excipient focus: .ALPHA.-TOCOPHEROL
tapentadol hydrochloride drug variants containing .ALPHA.-TOCOPHEROL
tapentadol hydrochloride drug variants not containing .ALPHA.-TOCOPHEROL
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0942 |
| Stat Rx USA | tapentadol hydrochloride | 16590-863 |
| STAT RX USA LLC | tapentadol hydrochloride | 16590-889 |
| Rebel Distributors Corp | tapentadol hydrochloride | 21695-069 |
| >Company | >Ingredient | >NDC |
Excipient focus: ALUMINUM OXIDE
tapentadol hydrochloride drug variants containing ALUMINUM OXIDE
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0942 |
| Stat Rx USA | tapentadol hydrochloride | 16590-863 |
| STAT RX USA LLC | tapentadol hydrochloride | 16590-889 |
| Rebel Distributors Corp | tapentadol hydrochloride | 21695-069 |
| >Company | >Ingredient | >NDC |
tapentadol hydrochloride drug variants not containing ALUMINUM OXIDE
Excipient focus: ANHYDROUS CITRIC ACID
tapentadol hydrochloride drug variants containing ANHYDROUS CITRIC ACID
| Company | Ingredient | NDC |
|---|---|---|
| ANI Pharmaceuticals Inc | tapentadol hydrochloride | 70954-801 |
| >Company | >Ingredient | >NDC |
tapentadol hydrochloride drug variants not containing ANHYDROUS CITRIC ACID
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0936 |
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0942 |
| Stat Rx USA | tapentadol hydrochloride | 16590-863 |
| STAT RX USA LLC | tapentadol hydrochloride | 16590-889 |
| >Company | >Ingredient | >NDC |
Excipient focus: CARAMEL
tapentadol hydrochloride drug variants containing CARAMEL
| Company | Ingredient | NDC |
|---|---|---|
| EPIC PHARMA LLC | tapentadol hydrochloride | 42806-626 |
| >Company | >Ingredient | >NDC |
tapentadol hydrochloride drug variants not containing CARAMEL
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0936 |
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0942 |
| Stat Rx USA | tapentadol hydrochloride | 16590-863 |
| STAT RX USA LLC | tapentadol hydrochloride | 16590-889 |
| >Company | >Ingredient | >NDC |
Excipient focus: CELLULOSE, MICROCRYSTALLINE
tapentadol hydrochloride drug variants containing CELLULOSE, MICROCRYSTALLINE
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0942 |
| Stat Rx USA | tapentadol hydrochloride | 16590-863 |
| STAT RX USA LLC | tapentadol hydrochloride | 16590-889 |
| Rebel Distributors Corp | tapentadol hydrochloride | 21695-069 |
| >Company | >Ingredient | >NDC |
tapentadol hydrochloride drug variants not containing CELLULOSE, MICROCRYSTALLINE
Excipient focus: COPOVIDONE K25-31
tapentadol hydrochloride drug variants containing COPOVIDONE K25-31
| Company | Ingredient | NDC |
|---|---|---|
| EPIC PHARMA LLC | tapentadol hydrochloride | 42806-626 |
| >Company | >Ingredient | >NDC |
tapentadol hydrochloride drug variants not containing COPOVIDONE K25-31
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0936 |
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0942 |
| Stat Rx USA | tapentadol hydrochloride | 16590-863 |
| STAT RX USA LLC | tapentadol hydrochloride | 16590-889 |
| >Company | >Ingredient | >NDC |
Excipient focus: CROSCARMELLOSE SODIUM
tapentadol hydrochloride drug variants containing CROSCARMELLOSE SODIUM
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0942 |
| Stat Rx USA | tapentadol hydrochloride | 16590-863 |
| STAT RX USA LLC | tapentadol hydrochloride | 16590-889 |
| Rebel Distributors Corp | tapentadol hydrochloride | 21695-069 |
| >Company | >Ingredient | >NDC |
tapentadol hydrochloride drug variants not containing CROSCARMELLOSE SODIUM
Excipient focus: FD&C BLUE NO. 2
tapentadol hydrochloride drug variants containing FD&C BLUE NO. 2
| Company | Ingredient | NDC |
|---|---|---|
| LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC | tapentadol hydrochloride | 55700-555 |
| >Company | >Ingredient | >NDC |
tapentadol hydrochloride drug variants not containing FD&C BLUE NO. 2
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0936 |
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0942 |
| Stat Rx USA | tapentadol hydrochloride | 16590-863 |
| STAT RX USA LLC | tapentadol hydrochloride | 16590-889 |
| >Company | >Ingredient | >NDC |
Excipient focus: FERROSOFERRIC OXIDE
tapentadol hydrochloride drug variants containing FERROSOFERRIC OXIDE
tapentadol hydrochloride drug variants not containing FERROSOFERRIC OXIDE
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0942 |
| Stat Rx USA | tapentadol hydrochloride | 16590-863 |
| STAT RX USA LLC | tapentadol hydrochloride | 16590-889 |
| Rebel Distributors Corp | tapentadol hydrochloride | 21695-069 |
| >Company | >Ingredient | >NDC |
Excipient focus: HYPROMELLOSE
tapentadol hydrochloride drug variants containing HYPROMELLOSE
tapentadol hydrochloride drug variants not containing HYPROMELLOSE
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0942 |
| Stat Rx USA | tapentadol hydrochloride | 16590-863 |
| STAT RX USA LLC | tapentadol hydrochloride | 16590-889 |
| Rebel Distributors Corp | tapentadol hydrochloride | 21695-069 |
| >Company | >Ingredient | >NDC |
Excipient focus: LACTOSE MONOHYDRATE
tapentadol hydrochloride drug variants containing LACTOSE MONOHYDRATE
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0942 |
| Stat Rx USA | tapentadol hydrochloride | 16590-863 |
| STAT RX USA LLC | tapentadol hydrochloride | 16590-889 |
| Rebel Distributors Corp | tapentadol hydrochloride | 21695-069 |
| >Company | >Ingredient | >NDC |
tapentadol hydrochloride drug variants not containing LACTOSE MONOHYDRATE
Excipient focus: MAGNESIUM STEARATE
tapentadol hydrochloride drug variants containing MAGNESIUM STEARATE
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0942 |
| Stat Rx USA | tapentadol hydrochloride | 16590-863 |
| STAT RX USA LLC | tapentadol hydrochloride | 16590-889 |
| Rebel Distributors Corp | tapentadol hydrochloride | 21695-069 |
| >Company | >Ingredient | >NDC |
tapentadol hydrochloride drug variants not containing MAGNESIUM STEARATE
Excipient focus: POLYETHYLENE GLYCOL
tapentadol hydrochloride drug variants containing POLYETHYLENE GLYCOL
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0936 |
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0942 |
| Stat Rx USA | tapentadol hydrochloride | 16590-863 |
| STAT RX USA LLC | tapentadol hydrochloride | 16590-889 |
| >Company | >Ingredient | >NDC |
tapentadol hydrochloride drug variants not containing POLYETHYLENE GLYCOL
| Company | Ingredient | NDC |
|---|---|---|
| EPIC PHARMA LLC | tapentadol hydrochloride | 42806-626 |
| ANI Pharmaceuticals Inc | tapentadol hydrochloride | 70954-801 |
| >Company | >Ingredient | >NDC |
Excipient focus: POLYETHYLENE GLYCOL 4000
tapentadol hydrochloride drug variants containing POLYETHYLENE GLYCOL 4000
| Company | Ingredient | NDC |
|---|---|---|
| EPIC PHARMA LLC | tapentadol hydrochloride | 42806-626 |
| >Company | >Ingredient | >NDC |
tapentadol hydrochloride drug variants not containing POLYETHYLENE GLYCOL 4000
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0936 |
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0942 |
| Stat Rx USA | tapentadol hydrochloride | 16590-863 |
| STAT RX USA LLC | tapentadol hydrochloride | 16590-889 |
| >Company | >Ingredient | >NDC |
Excipient focus: POLYVINYL ALCOHOL
tapentadol hydrochloride drug variants containing POLYVINYL ALCOHOL
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0936 |
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0942 |
| Stat Rx USA | tapentadol hydrochloride | 16590-863 |
| STAT RX USA LLC | tapentadol hydrochloride | 16590-889 |
| >Company | >Ingredient | >NDC |
tapentadol hydrochloride drug variants not containing POLYVINYL ALCOHOL
| Company | Ingredient | NDC |
|---|---|---|
| ANI Pharmaceuticals Inc | tapentadol hydrochloride | 70954-801 |
| >Company | >Ingredient | >NDC |
Excipient focus: POVIDONE
tapentadol hydrochloride drug variants containing POVIDONE
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0942 |
| Stat Rx USA | tapentadol hydrochloride | 16590-863 |
| STAT RX USA LLC | tapentadol hydrochloride | 16590-889 |
| Rebel Distributors Corp | tapentadol hydrochloride | 21695-069 |
| >Company | >Ingredient | >NDC |
tapentadol hydrochloride drug variants not containing POVIDONE
Excipient focus: PROPYLENE GLYCOL
tapentadol hydrochloride drug variants containing PROPYLENE GLYCOL
tapentadol hydrochloride drug variants not containing PROPYLENE GLYCOL
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0942 |
| Stat Rx USA | tapentadol hydrochloride | 16590-863 |
| STAT RX USA LLC | tapentadol hydrochloride | 16590-889 |
| Rebel Distributors Corp | tapentadol hydrochloride | 21695-069 |
| >Company | >Ingredient | >NDC |
Excipient focus: SHELLAC
tapentadol hydrochloride drug variants containing SHELLAC
tapentadol hydrochloride drug variants not containing SHELLAC
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0942 |
| Stat Rx USA | tapentadol hydrochloride | 16590-863 |
| STAT RX USA LLC | tapentadol hydrochloride | 16590-889 |
| Rebel Distributors Corp | tapentadol hydrochloride | 21695-069 |
| >Company | >Ingredient | >NDC |
Excipient focus: SILICON DIOXIDE
tapentadol hydrochloride drug variants containing SILICON DIOXIDE
| Company | Ingredient | NDC |
|---|---|---|
| EPIC PHARMA LLC | tapentadol hydrochloride | 42806-626 |
| >Company | >Ingredient | >NDC |
tapentadol hydrochloride drug variants not containing SILICON DIOXIDE
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0936 |
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0942 |
| Stat Rx USA | tapentadol hydrochloride | 16590-863 |
| STAT RX USA LLC | tapentadol hydrochloride | 16590-889 |
| >Company | >Ingredient | >NDC |
Excipient focus: SODIUM HYDROXIDE
tapentadol hydrochloride drug variants containing SODIUM HYDROXIDE
| Company | Ingredient | NDC |
|---|---|---|
| ANI Pharmaceuticals Inc | tapentadol hydrochloride | 70954-801 |
| >Company | >Ingredient | >NDC |
tapentadol hydrochloride drug variants not containing SODIUM HYDROXIDE
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0936 |
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0942 |
| Stat Rx USA | tapentadol hydrochloride | 16590-863 |
| STAT RX USA LLC | tapentadol hydrochloride | 16590-889 |
| >Company | >Ingredient | >NDC |
Excipient focus: SUCRALOSE
tapentadol hydrochloride drug variants containing SUCRALOSE
| Company | Ingredient | NDC |
|---|---|---|
| ANI Pharmaceuticals Inc | tapentadol hydrochloride | 70954-801 |
| >Company | >Ingredient | >NDC |
tapentadol hydrochloride drug variants not containing SUCRALOSE
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0936 |
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0942 |
| Stat Rx USA | tapentadol hydrochloride | 16590-863 |
| STAT RX USA LLC | tapentadol hydrochloride | 16590-889 |
| >Company | >Ingredient | >NDC |
Excipient focus: TALC
tapentadol hydrochloride drug variants containing TALC
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0936 |
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0942 |
| Stat Rx USA | tapentadol hydrochloride | 16590-863 |
| STAT RX USA LLC | tapentadol hydrochloride | 16590-889 |
| >Company | >Ingredient | >NDC |
tapentadol hydrochloride drug variants not containing TALC
| Company | Ingredient | NDC |
|---|---|---|
| ANI Pharmaceuticals Inc | tapentadol hydrochloride | 70954-801 |
| >Company | >Ingredient | >NDC |
Excipient focus: TITANIUM DIOXIDE
tapentadol hydrochloride drug variants containing TITANIUM DIOXIDE
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0936 |
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0942 |
| Stat Rx USA | tapentadol hydrochloride | 16590-863 |
| STAT RX USA LLC | tapentadol hydrochloride | 16590-889 |
| >Company | >Ingredient | >NDC |
tapentadol hydrochloride drug variants not containing TITANIUM DIOXIDE
| Company | Ingredient | NDC |
|---|---|---|
| ANI Pharmaceuticals Inc | tapentadol hydrochloride | 70954-801 |
| >Company | >Ingredient | >NDC |
Excipient focus: WATER
tapentadol hydrochloride drug variants containing WATER
| Company | Ingredient | NDC |
|---|---|---|
| ANI Pharmaceuticals Inc | tapentadol hydrochloride | 70954-801 |
| >Company | >Ingredient | >NDC |
tapentadol hydrochloride drug variants not containing WATER
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0936 |
| Hikma Pharmaceuticals USA Inc | tapentadol hydrochloride | 0054-0942 |
| Stat Rx USA | tapentadol hydrochloride | 16590-863 |
| STAT RX USA LLC | tapentadol hydrochloride | 16590-889 |
| >Company | >Ingredient | >NDC |
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