| NDC Code | 76420-534-30 |
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| Package Description | 30 TABLET in 1 BOTTLE, PLASTIC (76420-534-30) |
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| Product NDC | 76420-534 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate |
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| Non-Proprietary Name | Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate |
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| Dosage Form | TABLET |
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| Usage | SUBLINGUAL |
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| Start Marketing Date | 20210122 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA209069 |
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| Manufacturer | Asclemed USA, Inc. |
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| Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE |
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| Strength | 8; 2 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA] |
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| DEA Schedule | CIII |
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