Product NDC: | 10914-552 |
Proprietary Name: | hydrocodone bitartrate and acetaminophen |
Non Proprietary Name: | hydrocodone bitartrate and acetaminophen |
Active Ingredient(s): | 300; 10 mg/1; mg/1 & nbsp; hydrocodone bitartrate and acetaminophen |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 10914-552 |
Labeler Name: | Brighton Pharmaceuticals, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA040556 |
Marketing Category: | ANDA |
Start Marketing Date: | 20070419 |
Package NDC: | 10914-552-01 |
Package Description: | 100 TABLET in 1 BOTTLE, PLASTIC (10914-552-01) |
NDC Code | 10914-552-01 |
Proprietary Name | hydrocodone bitartrate and acetaminophen |
Package Description | 100 TABLET in 1 BOTTLE, PLASTIC (10914-552-01) |
Product NDC | 10914-552 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | hydrocodone bitartrate and acetaminophen |
Dosage Form Name | TABLET |
Route Name | ORAL |
Start Marketing Date | 20070419 |
Marketing Category Name | ANDA |
Labeler Name | Brighton Pharmaceuticals, Inc. |
Substance Name | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
Strength Number | 300; 10 |
Strength Unit | mg/1; mg/1 |
Pharmaceutical Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |