| NDC Code | 68083-696-05 |
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| Package Description | 5 VIAL in 1 CARTON (68083-696-05) / 1 mL in 1 VIAL |
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| Product NDC | 68083-696 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Buprenorphine Hydrochloride |
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| Non-Proprietary Name | Buprenorphine Hydrochloride |
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| Dosage Form | INJECTION |
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| Usage | INTRAMUSCULAR; INTRAVENOUS |
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| Start Marketing Date | 20261015 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA221145 |
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| Manufacturer | Gland Pharma Limited |
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| Substance Name | BUPRENORPHINE HYDROCHLORIDE |
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| Strength | .324 |
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| Strength Unit | mg/mL |
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| Pharmacy Classes | Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA] |
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| DEA Schedule | CIII |
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