Buprenorphine HCl and Naloxone HCl - Buprenorphine and Naloxone
Navigation: NDC > Supplier starting with: A > AMNEAL PHARMACEUTICALS, LLC| Field | Value |
|---|---|
| NDC Code: | 65162-415 |
| Proprietary Name: | Buprenorphine HCl and Naloxone HCl |
| Suffix: | |
| Non-Proprietary Name: | Buprenorphine and Naloxone |
| Dosage Form: | TABLET |
| Method: | SUBLINGUAL |
| Original Marketing Date: | 22-02-2013 |
| Category Name: | ANDA |
| Application Number: | ANDA203136 |
| Labeler: | AMNEAL PHARMACEUTICALS, LLC |
| Substance Name: | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE |
| Active Numerator Strength: | 8; 2 |
| Active Ingredient Unit: | mg/1; mg/1 |
| Pharm Classes: | Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] |
| DEA Schedule: | CIII |