Omeprazole 20 mg

Product NDC: 25000-094
11-digit product format: 250000094
Labeler code: 25000
Product ID: 25000-094_a18acd7b-add6-4935-a0dd-7b2a27d817ab
Type: HUMAN OTC DRUG
Nonproprietary name: Omeprazole 20 mg
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: MARKSANS PHARMA LIMITED
Application: ANDA218829
Marketing category: ANDA
Marketing start: 2026-08-05
Substance: OMEPRAZOLE MAGNESIUM
Active strength: 20 mg/1
Pharmacologic classes: Cytochrome P450 2C19 Inhibitors [MoA]; Proton Pump Inhibitor [EPC]; Proton Pump Inhibitors [MoA]
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A218829-001	OMEPRAZOLE MAGNESIUM	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL			2025-08-07

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A218829-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2025-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218829-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2025-08-07	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218829-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2025-08-07	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Omeprazole 20 mg
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMEPRAZOLE MAGNESIUM	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
426QFE7XLK	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5baf6e08-8a5a-4ec0-af6d-eb73c6487e0c	Available on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole 20 mg	OMEPRAZOLE 20 MG	MARKSANS PHARMA LIMITED	5baf6e08-8a5a-4ec0-af6d-eb73c6487e0c	2026-08-05	Warnings	Exact identifier application applno (ANDA): 218829 application number: ANDA218829 ndc (product): 25000-094
Omeprazole Delayed-Release	OMEPRAZOLE	H-E-B	448ba584-6a6e-3d85-e063-6294a90a5579	2026-04-29	Warnings	Exact identifier application applno (ANDA): 218829 application number: ANDA218829
24 HOUR Omeprazole	OMEPRAZOLE 20 MG	Grocery Outlet, Inc.	4466f17c-c27b-8393-e063-6394a90a803d	2026-03-23	Warnings	Exact identifier application applno (ANDA): 218829 application number: ANDA218829
Omeprazole delayed release	OMEPRAZOLE 20MG	TIME CAP LABORATORIES, INC.	40906798-cd84-fbd0-e063-6294a90a1d29	2025-11-22	Warnings	Exact identifier application applno (ANDA): 218829 application number: ANDA218829
Omeprazole 20 mg	OMEPRAZOLE 20 MG	MARKSANS PHARMA LIMITED	921bf750-9dd7-42ff-82bb-043b03f0fe69	2025-08-11	Warnings	Exact identifier application applno (ANDA): 218829 application number: ANDA218829

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
426QFE7XLK	OMEPRAZOLE MAGNESIUM	95382-33-5	OMEPRAZOLE MAGNESIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Status
25000-094-76	25000009476	1 BOTTLE in 1 CARTON (25000-094-76) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE	1 bottle	2026-08-05	0	Current
25000-094-81	25000009481	1 BLISTER PACK in 1 CARTON (25000-094-81) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK	1 blister pack	2026-08-05	0	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole Delayed-Release Tablets 20 mg (Wildberry Mint Coated Tablets)	MARKSANS PHARMA LIMITED	2026-08-05	Human OTC Drug Label	2