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IBUDONE
IBUDONE - 50991-579-01 - (hydrocodone bitartrate and ibuprofen)
Drug Information of IBUDONE
| Product NDC: | 50991-579 |
| Proprietary Name: | IBUDONE |
| Non Proprietary Name: | hydrocodone bitartrate and ibuprofen |
| Active Ingredient(s): | 10; 200 mg/1; mg/1 & nbsp; hydrocodone bitartrate and ibuprofen |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of IBUDONE
| Product NDC: | 50991-579 |
| Labeler Name: | Poly Pharmaceuticals |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA077723 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20061106 |
Package Information of IBUDONE
| Package NDC: | 50991-579-01 |
| Package Description: | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50991-579-01) |
NDC Information of IBUDONE
| NDC Code | 50991-579-01 |
| Proprietary Name | IBUDONE |
| Package Description | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50991-579-01) |
| Product NDC | 50991-579 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | hydrocodone bitartrate and ibuprofen |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20061106 |
| Marketing Category Name | ANDA |
| Labeler Name | Poly Pharmaceuticals |
| Substance Name | HYDROCODONE BITARTRATE; IBUPROFEN |
| Strength Number | 10; 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] |
