Hydrocodone Bitartate and Acetaminophen - HYDROCODONE BITARTRATE, ACETAMINOPHEN
Navigation: NDC > Supplier starting with: K > KLE 2, INC.| Field | Value |
|---|---|
| NDC Code: | 76218-1828 |
| Proprietary Name: | Hydrocodone Bitartate and Acetaminophen |
| Suffix: | |
| Non-Proprietary Name: | HYDROCODONE BITARTRATE, ACETAMINOPHEN |
| Dosage Form: | TABLET |
| Method: | ORAL |
| Original Marketing Date: | 17-05-2012 |
| Category Name: | ANDA |
| Application Number: | ANDA040846 |
| Labeler: | KLE 2, INC. |
| Substance Name: | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
| Active Numerator Strength: | 325; 2.5 |
| Active Ingredient Unit: | mg/1; mg/1 |
| Pharm Classes: | Opioid Agonist [EPC],Opioid Agonists [MoA] |
| DEA Schedule: | CIII |