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Reprexain
Reprexain - 16590-878-40 - (Hydrocodone Bitartrate, Ibuprofen)
Drug Information of Reprexain
| Product NDC: | 16590-878 |
| Proprietary Name: | Reprexain |
| Non Proprietary Name: | Hydrocodone Bitartrate, Ibuprofen |
| Active Ingredient(s): | 5; 200 mg/1; mg/1 & nbsp; Hydrocodone Bitartrate, Ibuprofen |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Reprexain
| Product NDC: | 16590-878 |
| Labeler Name: | Stat Rx USA |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA076642 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20081216 |
Package Information of Reprexain
| Package NDC: | 16590-878-40 |
| Package Description: | 40 TABLET, FILM COATED in 1 BOTTLE (16590-878-40) |
NDC Information of Reprexain
| NDC Code | 16590-878-40 |
| Proprietary Name | Reprexain |
| Package Description | 40 TABLET, FILM COATED in 1 BOTTLE (16590-878-40) |
| Product NDC | 16590-878 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Hydrocodone Bitartrate, Ibuprofen |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20081216 |
| Marketing Category Name | ANDA |
| Labeler Name | Stat Rx USA |
| Substance Name | HYDROCODONE BITARTRATE; IBUPROFEN |
| Strength Number | 5; 200 |
| Strength Unit | mg/1; mg/1 |
| Pharmaceutical Classes | Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] |
