Omeprazole delayed release

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 delayed release
Generic name: OMEPRAZOLE 20MG
Manufacturer: TIME CAP LABORATORIES, INC.
Product type: HUMAN OTC DRUG
SPL set ID: 40906798-cd84-fbd0-e063-6294a90a1d29
SPL ID: 442e2a90-4ac6-8adf-e063-6394a90a6fc2
Version: 2
Effective date: 2025-11-22
Source export date: 2026-10-30
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/9dea423b9e87a781c152bc6e136923fb91acb0732a7a0ec0d2a51142148f160c/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:42:53

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 delayed release	openfda.brand_name
generic name		OMEPRAZOLE 20MG	openfda.generic_name
manufacturer name		TIME CAP LABORATORIES, INC.	openfda.manufacturer_name
ndc	package	49483-731-45	openfda.package_ndc
ndc	package	49483-731-41	openfda.package_ndc
ndc	product	49483-731	openfda.product_ndc
ndc11	package	49483073141	derived:openfda.package_ndc
ndc11	package	49483073145	derived:openfda.package_ndc
rxcui		402014	openfda.rxcui
spl id		442e2a90-4ac6-8adf-e063-6394a90a6fc2	id
spl set id		40906798-cd84-fbd0-e063-6294a90a1d29	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 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 attention right away.

Reported adverse events (FAERS/openFDA)#

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