Product NDC: | 45865-411 |
Proprietary Name: | HYDROCODONE BIT/APAP |
Non Proprietary Name: | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
Active Ingredient(s): | 325; 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: | 45865-411 |
Labeler Name: | Medsource Pharmaceuticals |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA040400 |
Marketing Category: | ANDA |
Start Marketing Date: | 20110701 |
Package NDC: | 45865-411-12 |
Package Description: | 12 TABLET in 1 BOTTLE (45865-411-12) |
NDC Code | 45865-411-12 |
Proprietary Name | HYDROCODONE BIT/APAP |
Package Description | 12 TABLET in 1 BOTTLE (45865-411-12) |
Product NDC | 45865-411 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
Dosage Form Name | TABLET |
Route Name | ORAL |
Start Marketing Date | 20110701 |
Marketing Category Name | ANDA |
Labeler Name | Medsource Pharmaceuticals |
Substance Name | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
Strength Number | 325; 10 |
Strength Unit | mg/1; mg/1 |
Pharmaceutical Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |