| NDC Code | 53217-328-01 |
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| Package Description | 30 POUCH in 1 CARTON (53217-328-01) > 1 FILM, SOLUBLE in 1 POUCH |
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| Product NDC | 53217-328 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Suboxone |
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| Non-Proprietary Name | Buprenorphine Hydrochloride, Naloxone Hydrochloride |
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| Dosage Form | FILM, SOLUBLE |
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| Usage | SUBLINGUAL |
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| Start Marketing Date | 20100913 |
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| Marketing Category Name | NDA |
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| Application Number | NDA022410 |
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| Manufacturer | Aidarex Pharmaceuticals LLC |
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| Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
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| Strength | 8; 2 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA] |
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| DEA Schedule | CIII |
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