Label: MESALAMINE capsule, extended release
- NDC Code(s): 70771-1625-7
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 18, 2022
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INGREDIENTS AND APPEARANCE
MESALAMINE
mesalamine capsule, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1625 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MESALAMINE (UNII: 4Q81I59GXC) (MESALAMINE - UNII:4Q81I59GXC) MESALAMINE 0.375 g Inactive Ingredients Ingredient Name Strength ETHYLCELLULOSE (10 MPA.S) (UNII: 3DYK7UYZ62) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) TALC (UNII: 7SEV7J4R1U) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SUCROSE (UNII: C151H8M554) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color BLUE (opaque blue cap) , BLUE (opaque blue body) Score no score Shape CAPSULE Size 24mm Flavor Imprint Code 452 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1625-7 120 in 1 BOTTLE; Type 0: Not a Combination Product 08/13/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208954 08/13/2021 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (863362789) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1625) , MANUFACTURE(70771-1625)
