Omeprazole

Product NDC: 37835-001
11-digit product format: 378350001
Labeler code: 37835
Product ID: 37835-001_b5885abb-562a-4e2b-8a46-3d9153ec01a8
Type: HUMAN OTC DRUG
Nonproprietary name: Omeprazole
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: BI-MART
Application: ANDA207891
Marketing category: ANDA
Marketing start: 2019-09-30
Marketing end: 0000-00-00
Substance: OMEPRAZOLE
Active strength: 20 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	37835-001		E	Excluded after deficient or non-compliant submission was not corrected	2026-10-12
excluded package	package	37835-001	37835-001-14	E	Excluded after deficient or non-compliant submission was not corrected	2026-10-12
excluded package	package	37835-001	37835-001-42	E	Excluded after deficient or non-compliant submission was not corrected	2026-10-12

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.

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
424daadb-95de-8ece-97f5-235e3f7f0001	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
37835-001-14	Omeprazole	1 in 1 CARTON	TABLET, DELAYED RELEASE	1	4
37835-001-14	Omeprazole	14 in 1 BOTTLE	TABLET, DELAYED RELEASE	14	4
37835-001-42	Omeprazole	3 in 1 CARTON	TABLET, DELAYED RELEASE	3	4
37835-001-42	Omeprazole	14 in 1 BOTTLE	TABLET, DELAYED RELEASE	14	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37835-001	OMEPRAZOLE TABLET, DELAYED RELEASE [BI-MART]	4	Legacy NDC, 4 package rows	20250406_fb089d15-daa4-477a-be83-ecd55c3283d4.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 · 14 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
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	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
402014	omeprazole 20 MG Delayed Release Oral Tablet	PSN	fb089d15-daa4-477a-be83-ecd55c3283d4	4
402014	omeprazole 20 MG Delayed Release Oral Tablet	SCD	fb089d15-daa4-477a-be83-ecd55c3283d4	4
402014	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet	SY	fb089d15-daa4-477a-be83-ecd55c3283d4	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37835-001-14	37835000114	1 in 1 CARTON						Historical
37835-001-42	37835000142	3 BOTTLE in 1 CARTON (37835-001-42) > 14 TABLET, DELAYED RELEASE in 1 BOTTLE (37835-001-14)	3 bottle	2019-09-30	0000-00-00	No	No	Current