OMEPRAZOLE: Package Insert and Label Information

OMEPRAZOLE- omeprazole powder
Abbvil Chemical LLC

Omeprazole

86065-002-01
(click image for full-size original)

OMEPRAZOLE
omeprazole powder
Product Information
Product Type BULK INGREDIENT Item Code (Source) NDC:86065-002
Route of Administration NOT APPLICABLE DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE (OMEPRAZOLE) OMEPRAZOLE 0.99 kg in 1 kg
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86065-002-01 20 kg in 1 DRUM None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING 04/01/2016
Labeler — Abbvil Chemical LLC (005448211)
Establishment
Name Address ID/FEI Operations
Abbvil Chemical LLC 005448211 relabel (86065-002)
Establishment
Name Address ID/FEI Operations
Shouguang Fukang Pharmaceutical Co., Ltd. 544640915 api manufacture (86065-002)

Revised: 04/2016 Abbvil Chemical LLC

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.