Omeprazole

Product NDC: 53943-038
11-digit product format: 539430038
Labeler code: 53943
Product ID: 53943-038_58d39ad0-ccae-79fc-e063-6394a90ae403
Type: HUMAN OTC DRUG
Nonproprietary name: Omeprazole
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Discount Drug Mart, Inc
Application: ANDA207891
Marketing category: ANDA
Marketing start: 2026-09-01
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: 2027-12-31
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
A207891-001	OMEPRAZOLE	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL			2018-10-12

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.

Product history page 1 of 2 · 43 observed 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	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207891-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	2018-10-12	`f41ea6bd6efb…`

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: 2027-12-31

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
4d5f30c2-775d-a1a3-e063-6394a90a07ff	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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	Discount Drug Mart, Inc	4d5f30c2-775d-a1a3-e063-6394a90a07ff	2026-08-12	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891 ndc (product): 53943-038
omeprazole	OMEPRAZOLE	Little Pharma, Inc.	d4f86bbe-fe4d-41e2-96cc-4b4bbe2f1f7f	2026-03-16	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891
Omeprazole	OMEPRAZOLE	Redpharm Drug	44f59d88-d401-950b-e063-6294a90a2a50	2025-12-02	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891
Omeprazole	OMEPRAZOLE	Sun Pharmaceutical Industries, Inc.	51c3ef34-b7c1-419e-a784-ae82540c7a22	2025-04-28	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891
Omeprazole	OMEPRAZOLE	BI-MART	fb089d15-daa4-477a-be83-ecd55c3283d4	2025-04-03	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891
Omeprazole	OMEPRAZOLE	GERI-CARE PHARMACEUTICALS, CORP	8a77aea7-912e-43a3-bce3-f666b9b9c9bc	2024-11-22	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891
omeprazole	OMEPRAZOLE	INNOVUS PHARMACEUTICALS, INC.	7535a309-1a67-4f50-911b-7cf570322931	2024-10-30	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891
Omeprazole	OMEPRAZOLE	Living Better Brands LLC	1d500e2d-395b-437e-a95c-3922a71a0956	2024-08-12	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891
Omeprazole	OMEPRAZOLE	OHM LABORATORIES INC.	35a95bec-51b9-465b-aa93-ad26afb87be8	2024-02-29	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891
Omeprazole	OMEPRAZOLE	VALU MERCHANDISERS COMPANY	7b2d41b6-3e36-4973-b5f6-adf9b828f40d	2023-12-13	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891
Omeprazole	OMEPRAZOLE	STRATEGIC SOURCING SERVICES LLC	56380ccc-6fc2-4e1b-bd87-da24c9aa31cd	2023-08-14	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891
omeprazole	OMEPRAZOLE	THE KROGER COMPANY	f55cedc7-e0bc-4d30-af52-bfa881f6adde	2023-01-06	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891
Omeprazole	OMEPRAZOLE	Twin Med LLC	346141b5-b49d-489a-84eb-18df8b940460	2023-01-06	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891
Omeprazole	OMEPRAZOLE	HARRIS TEETER	c618964f-4b16-448e-851b-e6b2a816c660	2022-12-27	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891
Omeprazole	OMEPRAZOLE	Strategic Sourcing Services	dfa91081-3917-4dfc-9789-76800f57bb31	2022-05-11	Warnings	Exact identifier application applno (ANDA): 207891 application number: ANDA207891

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
53943-038-14	53943003814	1 BOTTLE in 1 CARTON (53943-038-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE	1 bottle	2026-09-01	No	No	Current
53943-038-42	53943003842	3 BOTTLE in 1 CARTON (53943-038-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE	3 bottle	2026-09-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole Delayed-release Tablets, 20 mg	Discount Drug Mart, Inc \| Sun Pharmaceutical Industries Inc. \| Sun Pharmaceutical Industries Limited	2026-08-12	HUMAN OTC DRUG LABEL	2