Omeprazole

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Omeprazole
Generic name: OMEPRAZOLE
Manufacturer: Sun Pharmaceutical Industries, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 51c3ef34-b7c1-419e-a784-ae82540c7a22
SPL ID: 676e2f39-d83e-485a-9366-ed14c382e466
Version: 5
Effective date: 2025-04-28
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:38:55

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 22 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	207891	derived:openfda.application_number
application number		ANDA207891	openfda.application_number
brand name		Omeprazole	openfda.brand_name
generic name		OMEPRAZOLE	openfda.generic_name
manufacturer name		Sun Pharmaceutical Industries, Inc.	openfda.manufacturer_name
ndc	package	62756-377-96	openfda.package_ndc
ndc	package	62756-377-12	openfda.package_ndc
ndc	package	62756-377-79	openfda.package_ndc
ndc	package	62756-377-11	openfda.package_ndc
ndc	package	62756-377-70	openfda.package_ndc
ndc	package	62756-377-21	openfda.package_ndc
ndc	product	62756-377	openfda.product_ndc
ndc11	package	62756037796	derived:openfda.package_ndc
ndc11	package	62756037770	derived:openfda.package_ndc
ndc11	package	62756037711	derived:openfda.package_ndc
ndc11	package	62756037712	derived:openfda.package_ndc
ndc11	package	62756037721	derived:openfda.package_ndc
ndc11	package	62756037779	derived:openfda.package_ndc
rxcui		402014	openfda.rxcui
spl id		676e2f39-d83e-485a-9366-ed14c382e466	id
spl set id		51c3ef34-b7c1-419e-a784-ae82540c7a22	set_id
unii		KG60484QX9	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Allergy alert: do not use if you are allergic to omeprazole • omeprazole may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If an allergic reaction occurs, stop use and seek medical help right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.