| NDC Code | 70518-4461-0 |
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| Package Description | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4461-0) |
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| Product NDC | 70518-4461 |
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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, FILM COATED |
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| Usage | ORAL |
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| Start Marketing Date | 20250828 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA207152 |
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| Manufacturer | REMEDYREPACK INC. |
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| Substance Name | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
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| Strength | 325; 37.5 |
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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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