| Product NDC: | 75987-010 |
| Proprietary Name: | DUEXIS |
| Non Proprietary Name: | Ibuprofen and Famotidine |
| Active Ingredient(s): | 26.6; 800 mg/1; mg/1 & nbsp; Ibuprofen and Famotidine |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 75987-010 |
| Labeler Name: | Horizon Pharma Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022519 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20110429 |
| Package NDC: | 75987-010-71 |
| Package Description: | 15 BLISTER PACK in 1 BLISTER PACK (75987-010-71) > 1 TABLET, COATED in 1 BLISTER PACK |
| NDC Code | 75987-010-71 |
| Proprietary Name | DUEXIS |
| Package Description | 15 BLISTER PACK in 1 BLISTER PACK (75987-010-71) > 1 TABLET, COATED in 1 BLISTER PACK |
| Product NDC | 75987-010 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Ibuprofen and Famotidine |
| Dosage Form Name | TABLET, COATED |
| Route Name | ORAL |
| Start Marketing Date | 20110429 |
| Marketing Category Name | NDA |
| Labeler Name | Horizon Pharma Inc. |
| Substance Name | FAMOTIDINE; IBUPROFEN |
| Strength Number | 26.6; 800 |
| Strength Unit | mg/1; mg/1 |
| Pharmaceutical Classes | Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] |