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: 5baf6e08-8a5a-4ec0-af6d-eb73c6487e0c
SPL ID: a18acd7b-add6-4935-a0dd-7b2a27d817ab
Version: 2
Effective date: 2026-08-05
Source export date: 2026-11-06
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/968b7138703f8100b14008bced2b2a4531f4fab250b207279e9c05eb19608f40/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run: 20261106T075659Z
Imported at: 2026-11-06 08:14:38

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	25000-094-76	openfda.package_ndc
ndc	package	25000-094-81	openfda.package_ndc
ndc	product	25000-094	openfda.product_ndc
ndc11	package	25000009481	derived:openfda.package_ndc
ndc11	package	25000009476	derived:openfda.package_ndc
rxcui		402014	openfda.rxcui
spl id		a18acd7b-add6-4935-a0dd-7b2a27d817ab	id
spl set id		5baf6e08-8a5a-4ec0-af6d-eb73c6487e0c	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 may include: o skin reddening o blisters o 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.