| NDC Code | 35356-661-00 |
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| Package Description | 100 TABLET, COATED in 1 BOTTLE (35356-661-00) |
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| Product NDC | 35356-661 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Tramadol Hydrochloride And Acetaminophen |
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| Non-Proprietary Name | Tramadol Hydrochloride And Acetaminophen |
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| Dosage Form | TABLET, COATED |
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| Usage | ORAL |
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| Start Marketing Date | 20010815 |
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| Marketing Category Name | NDA |
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| Application Number | NDA021123 |
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| Manufacturer | Lake Erie Medical DBA Quality Care Products LLC |
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| Substance Name | TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN |
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| Strength | 37.5; 325 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
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| DEA Schedule | CIV |
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