Omeprazole

Product NDC: 69168-476
11-digit product format: 691680476
Labeler code: 69168
Product ID: 69168-476_37309c28-8650-401e-9a39-6b52112e0baf
Type: HUMAN OTC DRUG
Nonproprietary name: Omeprazole
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Allegiant Health
Application: ANDA211732
Marketing category: ANDA
Marketing start: 2025-03-21
Substance: OMEPRAZOLE
Active strength: 20 mg/1
Pharmacologic classes: Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A211732-001	OMEPRAZOLE MAGNESIUM	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL			2020-03-25

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
2026-09-14 22:38:34	2026-08	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211732-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-03-25	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Omeprazole
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMEPRAZOLE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
KG60484QX9	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
402014	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
3344c589-c4ac-4f2d-8d32-828db4e825a6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1	Product name	5	20210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69168-476-14	Omeprazole	1 in 1 CARTON	TABLET, DELAYED RELEASE	1	2
69168-476-14	Omeprazole	14 in 1 BOTTLE	TABLET, DELAYED RELEASE	14	2
69168-476-15	Omeprazole	14 in 1 BOTTLE	TABLET, DELAYED RELEASE	14	2
69168-476-42	Omeprazole	3 in 1 CARTON	TABLET, DELAYED RELEASE	3	2
69168-476-42	Omeprazole	14 in 1 BOTTLE	TABLET, DELAYED RELEASE	14	2
69168-476-61	Omeprazole	14 in 1 BOTTLE	TABLET, DELAYED RELEASE	14	2
69168-476-61	Omeprazole	1 in 1 CARTON	TABLET, DELAYED RELEASE	1	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69168-476	OMEPRAZOLE TABLET, DELAYED RELEASE [ALLEGIANT HEALTH]	2	Current NDC, 7 package rows	20250327_3344c589-c4ac-4f2d-8d32-828db4e825a6.zip

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
GoodMeds 24HR Acid Reducer Omeprazole 20mg	OMEPRAZOLE 20MG	Cabinet Health P.B.C.	58c9c8ef-b929-14eb-e063-6294a90a3761	2026-08-11	Warnings	Exact identifier application applno (ANDA): 211732 application number: ANDA211732
Omeprazole	OMEPRAZOLE	Allegiant Health	3344c589-c4ac-4f2d-8d32-828db4e825a6	2025-03-19	Warnings	Exact identifier application applno (ANDA): 211732 application number: ANDA211732 ndc (product): 69168-476
Omeprazole	OMEPRAZOLE	CHAIN DRUG MARKETING ASSOCIATION, INC.	da09aac6-8fce-448b-98ba-1fc9bce42075	2024-04-17	Warnings	Exact identifier application applno (ANDA): 211732 application number: ANDA211732
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	a52842ac-ac9d-4344-9823-b8b2afb07903	2023-12-14	Warnings	Exact identifier application applno (ANDA): 211732 application number: ANDA211732
Omeprazole	OMEPRAZOLE	Camber Consumer Care Inc	9c856d3a-e38f-4006-a43a-ec1a9fa0f057	2022-11-28	Warnings	Exact identifier application applno (ANDA): 211732 application number: ANDA211732

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
KG60484QX9	OMEPRAZOLE	73590-58-6	OMEPRAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
402014	omeprazole 20 MG Delayed Release Oral Tablet	PSN	3344c589-c4ac-4f2d-8d32-828db4e825a6	2
402014	omeprazole 20 MG Delayed Release Oral Tablet	SCD	3344c589-c4ac-4f2d-8d32-828db4e825a6	2
402014	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet	SY	3344c589-c4ac-4f2d-8d32-828db4e825a6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69168-476-14	69168047614	1 BOTTLE in 1 CARTON (69168-476-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE	1 bottle	2025-03-21	No	No	Current
69168-476-15	69168047615	14 TABLET, DELAYED RELEASE in 1 BOTTLE (69168-476-15)		2025-03-21	No	No	Current
69168-476-42	69168047642	3 BOTTLE in 1 CARTON (69168-476-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE	3 bottle	2025-03-21	No	No	Current
69168-476-61	69168047661	1 BOTTLE in 1 CARTON (69168-476-61) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE	1 bottle	2025-03-21	No	No	Current