Label: TRAMADOL HYDROCHLORIDE tablet, film coated
- NDC Code(s): 65841-754-01, 65841-754-05, 65841-754-10, 65841-754-30
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: CIV
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 27, 2023
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INGREDIENTS AND APPEARANCE
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-754 Route of Administration ORAL DEA Schedule CIV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J) TRAMADOL HYDROCHLORIDE 50 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 9mm Flavor Imprint Code 319 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-754-30 10 in 1 CARTON 01/31/2011 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:65841-754-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/31/2011 3 NDC:65841-754-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/31/2011 4 NDC:65841-754-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/31/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090404 01/31/2011 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (677605858) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-754) , MANUFACTURE(65841-754) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 677605858 ANALYSIS(65841-754) , MANUFACTURE(65841-754)
