Label: INDOMETHACIN capsule
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NDC Code(s):
70771-1004-0,
70771-1004-1,
70771-1004-2,
70771-1004-5, view more70771-1005-0, 70771-1005-1, 70771-1005-2, 70771-1005-5
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 4, 2023
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- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
INDOMETHACIN
indomethacin capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1004 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength INDOMETHACIN (UNII: XXE1CET956) (INDOMETHACIN - UNII:XXE1CET956) INDOMETHACIN 50 mg Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE (UNII: XM0M87F357) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GELATIN (UNII: 2G86QN327L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POWDERED CELLULOSE (UNII: SMD1X3XO9M) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color GREEN (GREEN) Score no score Shape CAPSULE (CAPSULE) Size 19mm Flavor Imprint Code 294;50mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1004-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/21/2016 2 NDC:70771-1004-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 07/21/2016 3 NDC:70771-1004-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 07/21/2016 4 NDC:70771-1004-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 07/21/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090403 07/21/2016 INDOMETHACIN
indomethacin capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1005 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength INDOMETHACIN (UNII: XXE1CET956) (INDOMETHACIN - UNII:XXE1CET956) INDOMETHACIN 25 mg Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE (UNII: XM0M87F357) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GELATIN (UNII: 2G86QN327L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POWDERED CELLULOSE (UNII: SMD1X3XO9M) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color GREEN (GREEN) Score no score Shape CAPSULE (CAPSULE) Size 16mm Flavor Imprint Code 293;25mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1005-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/21/2016 2 NDC:70771-1005-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 07/21/2016 3 NDC:70771-1005-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 07/21/2016 4 NDC:70771-1005-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 07/21/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090403 07/21/2016 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1004, 70771-1005) , MANUFACTURE(70771-1004, 70771-1005)
