Label: INDOMETHACIN suppository
- NDC Code(s): 70771-1766-6, 70771-1766-7
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 3, 2023
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INGREDIENTS AND APPEARANCE
INDOMETHACIN
indomethacin suppositoryProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1766 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength INDOMETHACIN (UNII: XXE1CET956) (INDOMETHACIN - UNII:XXE1CET956) INDOMETHACIN 50 mg Inactive Ingredients Ingredient Name Strength HARD FAT (UNII: 8334LX7S21) Product Characteristics Color WHITE (off-white to yellowish white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1766-7 5 in 1 CARTON 08/03/2023 1 NDC:70771-1766-6 6 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 ANDA216184 08/03/2023 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 650650802 ANALYSIS(70771-1766) , MANUFACTURE(70771-1766)
