Omeprazole 20 mg

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 20 mg
Generic name: OMEPRAZOLE 20 MG
Manufacturer: MARKSANS PHARMA LIMITED
Product type: HUMAN OTC DRUG
SPL set ID: 921bf750-9dd7-42ff-82bb-043b03f0fe69
SPL ID: dcf79426-6aec-432a-aabe-dcb98c0f2cec
Version: 3
Effective date: 2025-08-11
Source export date: 2026-09-28
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:45:59

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	218829	derived:openfda.application_number
application number		ANDA218829	openfda.application_number
brand name		Omeprazole 20 mg	openfda.brand_name
generic name		OMEPRAZOLE 20 MG	openfda.generic_name
manufacturer name		MARKSANS PHARMA LIMITED	openfda.manufacturer_name
ndc	package	25000-091-77	openfda.package_ndc
ndc	package	25000-091-76	openfda.package_ndc
ndc	product	25000-091	openfda.product_ndc
ndc11	package	25000009176	derived:openfda.package_ndc
ndc11	package	25000009177	derived:openfda.package_ndc
rxcui		402014	openfda.rxcui
spl id		dcf79426-6aec-432a-aabe-dcb98c0f2cec	id
spl set id		921bf750-9dd7-42ff-82bb-043b03f0fe69	set_id
unii		426QFE7XLK	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 Warnings Allergy alert: Do not use if you are allergic to Omeprazole Omeprazole may cause severe skin reactions. Symptoms include: skin reddening blisters rash If an allergic reaction occurs, stop use and seek medical attention right away.

Reported adverse events (FAERS/openFDA)#

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