Label: OMEPRAZOLE powder
- NDC Code(s): 58597-7030-8, 58597-7030-9
- Packager: AMERICAN PHARMACEUTICAL INGREDIENTS LLC
- Category: BULK INGREDIENT
- DEA Schedule: None
- Marketing Status: Bulk Ingredient For Animal Drug Compounding
Drug Label Information
Updated August 12, 2013
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- PRINCIPAL DISPLAY PANEL – BULK PRODUCT
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INGREDIENTS AND APPEARANCE
OMEPRAZOLE
omeprazole powderProduct Information Product Type BULK INGREDIENT Item Code (Source) NDC:58597-7030 Route of Administration NOT APPLICABLE Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 1 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58597-7030-8 1000 g in 1 CONTAINER 2 NDC:58597-7030-9 5000 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date bulk ingredient for animal drug compounding 08/12/2013 Labeler - AMERICAN PHARMACEUTICAL INGREDIENTS LLC (078793641) Establishment Name Address ID/FEI Business Operations AMERICAN PHARMACEUTICAL INGREDIENTS LLC 078793641 repack(58597-7030) , relabel(58597-7030) Establishment Name Address ID/FEI Business Operations Shouguang Fukang Pharmaceutical Co., Ltd 544640915 api manufacture(58597-7030)
