| NDC Code | 54123-986-30 |
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| Package Description | 3 BLISTER PACK in 1 CARTON (54123-986-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
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| Product NDC | 54123-986 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Zubsolv |
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| Non-Proprietary Name | Buprenorphine Hydrochloride And Naloxone Hydrochloride |
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| Dosage Form | TABLET, ORALLY DISINTEGRATING |
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| Usage | SUBLINGUAL |
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| Start Marketing Date | 20141211 |
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| Marketing Category Name | NDA |
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| Application Number | NDA204242 |
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| Manufacturer | Orexo US, Inc. |
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| Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
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| Strength | 8.6; 2.1 |
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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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