| NDC Code | 33342-270-10 |
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| Package Description | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-270-10) |
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| Product NDC | 33342-270 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Tramadol Hydrochloride |
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| Non-Proprietary Name | Tramadol Hydrochloride |
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| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20250131 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA209404 |
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| Manufacturer | Macleods Pharmaceuticals Limited |
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| Substance Name | TRAMADOL HYDROCHLORIDE |
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| Strength | 200 |
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| Strength Unit | 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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