HYDROCODONE BIT/APAP - HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Navigation: NDC > Supplier starting with: M > MEDSOURCE PHARMACEUTICALS| Field | Value |
|---|---|
| NDC Code: | 45865-411 |
| Proprietary Name: | HYDROCODONE BIT/APAP |
| Suffix: | |
| Non-Proprietary Name: | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
| Dosage Form: | TABLET |
| Method: | ORAL |
| Original Marketing Date: | 01-07-2011 |
| Category Name: | ANDA |
| Application Number: | ANDA040400 |
| Labeler: | MEDSOURCE PHARMACEUTICALS |
| Substance Name: | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
| Active Numerator Strength: | 325; 10 |
| Active Ingredient Unit: | mg/1; mg/1 |
| Pharm Classes: | Opioid Agonist [EPC],Opioid Agonists [MoA] |
| DEA Schedule: | CIII |