Label: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN tablet, film coated
- NDC Code(s): 65841-758-01, 65841-758-05, 65841-758-10
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated September 27, 2023
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INGREDIENTS AND APPEARANCE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
tramadol hydrochloride and acetaminophen tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-758 Route of Administration ORAL DEA Schedule CIV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J) TRAMADOL HYDROCHLORIDE 37.5 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (WHITE) Score no score Shape CAPSULE (CAPSULE) Size 15mm Flavor Imprint Code 334 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-758-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/15/2012 2 NDC:65841-758-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 10/15/2012 3 NDC:65841-758-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 10/15/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090460 10/15/2012 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-758) , MANUFACTURE(65841-758)
