| NDC Code: |
76181-001 |
| Proprietary Name: |
hydrocodone bitartrate and acetaminophen |
| Suffix: |
|
| Non-Proprietary Name: |
hydrocodone bitartrate and acetaminophen |
| Dosage Form: |
SYRUP |
| Method: |
ORAL |
| Original Marketing Date: |
01-08-2011 |
| Category Name: |
ANDA |
| Application Number: |
ANDA040482 |
| Labeler: |
TALEC PHARMA, 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 |
