| NDC Code: |
53746-113 |
| Proprietary Name: |
Hydrocodone Bitartrate and Acetaminophen Tablets |
| Suffix: |
|
| Non-Proprietary Name: |
Hydrocodone Bitartrate and Acetaminophen |
| Dosage Form: |
TABLET |
| Method: |
ORAL |
| Original Marketing Date: |
18-02-2010 |
| Category Name: |
ANDA |
| Application Number: |
ANDA040754 |
| Labeler: |
AMNEAL PHARMACEUTICALS |
| Substance Name: |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
| Active Numerator Strength: |
650; 7.5 |
| Active Ingredient Unit: |
mg/1; mg/1 |
| Pharm Classes: |
Opioid Agonist [EPC],Opioid Agonists [MoA] |
| DEA Schedule: |
CIII |
