Product NDC: | 12634-978 |
Proprietary Name: | Hydrocodone Bitartrate and Acetaminophen |
Non Proprietary Name: | Hydrocodone Bitartrate and Acetaminophen |
Active Ingredient(s): | 500; 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: | 12634-978 |
Labeler Name: | Apotheca, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA040148 |
Marketing Category: | ANDA |
Start Marketing Date: | 20080701 |
Package NDC: | 12634-978-95 |
Package Description: | 5 TABLET in 1 BOTTLE, PLASTIC (12634-978-95) |
NDC Code | 12634-978-95 |
Proprietary Name | Hydrocodone Bitartrate and Acetaminophen |
Package Description | 5 TABLET in 1 BOTTLE, PLASTIC (12634-978-95) |
Product NDC | 12634-978 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Hydrocodone Bitartrate and Acetaminophen |
Dosage Form Name | TABLET |
Route Name | ORAL |
Start Marketing Date | 20080701 |
Marketing Category Name | ANDA |
Labeler Name | Apotheca, Inc. |
Substance Name | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
Strength Number | 500; 10 |
Strength Unit | mg/1; mg/1 |
Pharmaceutical Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |