Label: INDOMETHACIN capsule, extended release
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NDC Code(s):
70771-1203-0,
70771-1203-1,
70771-1203-2,
70771-1203-4, view more70771-1203-5, 70771-1203-6
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 26, 2023
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INGREDIENTS AND APPEARANCE
INDOMETHACIN
indomethacin capsule, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1203 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength INDOMETHACIN (UNII: XXE1CET956) (INDOMETHACIN - UNII:XXE1CET956) INDOMETHACIN 75 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) GELATIN (UNII: 2G86QN327L) SHELLAC (UNII: 46N107B71O) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) AMMONIA (UNII: 5138Q19F1X) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) WATER (UNII: 059QF0KO0R) Product Characteristics Color BLUE (DARK BLUE) , BLUE (DARK BLUE) Score no score Shape CAPSULE (CAPSULE) Size 19mm Flavor Imprint Code ZA;79;75mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1203-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2018 2 NDC:70771-1203-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2018 3 NDC:70771-1203-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2018 4 NDC:70771-1203-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2018 5 NDC:70771-1203-4 10 in 1 CARTON 02/08/2018 5 NDC:70771-1203-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202711 02/08/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1203) , MANUFACTURE(70771-1203)
