Omeprazole by AMERICAN PHARMACEUTICAL INGREDIENTS LLC / Shouguang Fukang Pharmaceutical Co., Ltd OMEPRAZOLE powder

Omeprazole by

Drug Labeling and Warnings

Omeprazole by is a Other medication manufactured, distributed, or labeled by AMERICAN PHARMACEUTICAL INGREDIENTS LLC, Shouguang Fukang Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL – BULK PRODUCT

INGREDIENTS AND APPEARANCE

OMEPRAZOLE 
omeprazole powder

Product 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)