NDC Code: |
64376-640 |
Proprietary Name: |
Hydrocodone Bitartrate and Acetaminophen |
Suffix: |
|
Non-Proprietary Name: |
Hydrocodone Bitartrate, Acetaminophen |
Dosage Form: |
SOLUTION |
Method: |
ORAL |
Original Marketing Date: |
27-07-2011 |
Category Name: |
ANDA |
Application Number: |
ANDA040894 |
Labeler: |
BOCA PHARMACAL, LLC |
Substance Name: |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
Active Numerator Strength: |
325; 7.5 |
Active Ingredient Unit: |
mg/15mL; mg/15mL |
Pharm Classes: |
Opioid Agonist [EPC],Opioid Agonists [MoA] |
DEA Schedule: |
CIII |