sunmark omeprazole

Product NDC: 49348-846
11-digit product format: 493480846
Labeler code: 49348
Product ID: 49348-846_c8cf49ab-7f9e-4ec4-a2a4-e79c29056cd5
Type: HUMAN OTC DRUG
Nonproprietary name: Omeprazole
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Strategic Sourcing Services LLC
Application: NDA022032
Marketing category: NDA
Marketing start: 2008-02-26
Marketing end: 0000-00-00
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: 2023-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49348-846		D	Discontinued by firm	2026-10-05
excluded package	package	49348-846	49348-846-46	D	Discontinued by firm	2026-10-05
excluded package	package	49348-846	49348-846-55	D	Discontinued by firm	2026-10-05
excluded package	package	49348-846	49348-846-61	D	Discontinued by firm	2026-10-05
excluded package	package	49348-846	49348-846-78	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 27 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49348-846-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49348-846-46	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49348-846-55	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49348-846-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49348-846-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49348-846-46	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49348-846-55	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49348-846-78	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49348-846-46	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49348-846-55	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49348-846-46	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49348-846-55	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49348-846-46	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49348-846-55	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49348-846-46	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49348-846-55	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49348-846-46	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49348-846-55	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49348-846-46	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49348-846-55	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49348-846-46	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49348-846-55	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49348-846-55	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49348-846-55	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49348-846-55	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N022032-001	OMEPRAZOLE	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL		RLD, RS	2007-12-04

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022032-001	12599565	2030-01-31		Drug product	2026-05-11

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022032-001	12599565	2030-01-31	Drug product	2026-05-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022032-001	12599565	2030-01-31	Drug product	2026-05-11	`caaa826d4ba7…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`e64feba35796…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-846-46	EA - Each	49348-846	9e5ea2bf-f254-4e62-babc-dca09bcabde1	1	2012-07-24
49348-846-61	EA - Each	49348-846	f31bdf5c-1346-4ee8-a480-5ba2ba7f832f	1	2012-07-24
49348-846-78	EA - Each	49348-846	0bcf206a-daf9-4aaa-9653-830238259c9e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	SUNMARK OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [MCKESSON]	3
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	SUNMARK OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [MCKESSON]	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	SUNMARK OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [MCKESSON]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SUNMARK OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [MCKESSON]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SUNMARK OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [MCKESSON]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SUNMARK OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [MCKESSON]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SUNMARK OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [MCKESSON]	3
MONOETHANOLAMINE	INACTIVE INGREDIENT	5KV86114PT	SUNMARK OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [MCKESSON]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SUNMARK OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [MCKESSON]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	SUNMARK OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [MCKESSON]	3
SODIUM STEARATE	INACTIVE INGREDIENT	QU7E2XA9TG	SUNMARK OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [MCKESSON]	3
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	SUNMARK OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [MCKESSON]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SUNMARK OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [MCKESSON]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SUNMARK OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [MCKESSON]	3
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SUNMARK OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [MCKESSON]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49348-846	SUNMARK OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [STRATEGIC SOURCING SERVICES LLC]	8	Legacy NDC	20241222_fe0bb8c5-9965-46f6-b675-773f2730d9f0.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 3 of 3 · 59 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	CVS Pharmacy	19b5b960-cc4d-42d0-8c8a-04a355a4db92	2024-09-13	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
omeprazole	OMEPRAZOLE	Publix Super Markets Inc	e4a68b0a-a550-4416-8911-1defe014ad89	2024-09-09	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
TopCare Omeprazole delayed release	OMEPRAZOLE	Topco Associates LLC	8ed57521-e69a-4563-9ce2-4f6d667f065d	2024-08-30	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
basic care omeprazole	OMEPRAZOLE	Amazon.com Services LLC	73c36634-a70f-4641-910f-6cdda7fbcd36	2024-08-08	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
topcare omeprazole	OMEPRAZOLE	Topco Associates LLC	ec9d8dab-480c-49bc-bdbb-bebcc7676d01	2024-08-06	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
up and up omeprazole	OMEPRAZOLE	Target Corporation	2f2b26fe-dbc2-4185-8a27-6b166dd49ba2	2024-07-26	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
up and up omeprazole	OMEPRAZOLE	Target Corporation	7dc339da-e90b-452b-b25e-8d7f3aa8bc18	2024-07-20	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
good sense omeprazole delayed release	OMEPRAZOLE	L. Perrigo Company	38082e59-c509-4be5-b29c-33a97565df1c	2024-06-27	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
members mark omeprazole	OMEPRAZOLE	Sam's West Inc	0edfa800-fb14-44dd-9c31-de930b864ef9	2024-06-25	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
basic care omeprazole	OMEPRAZOLE	Amazon.com Services LLC	76b941f0-a02f-43e8-821e-09ccf675d944	2024-06-17	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
good neighbor pharmacy omeprazole	OMEPRAZOLE	Amerisource Bergen	5ee3cb79-5c0c-456f-b5d5-d5a008bbd118	2024-04-26	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
omeprazole	OMEPRAZOLE	Publix Super Markets Inc	05fae639-ba68-4c05-8ca7-7c5cc2d50584	2024-04-16	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
Omeprazole	OMEPRAZOLE	Kroger Company	236a9447-23ec-44c7-a241-20f9ddc83ab8	2024-03-25	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
Good Sense Omeprazole	OMEPRAZOLE	L. Perrigo Company	db333c49-2c3e-4ade-a202-7d4499205fc4	2024-03-24	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
members mark omeprazole	OMEPRAZOLE	Sam's West Inc	907e9974-46b8-4dae-be92-518c076cb98f	2024-03-07	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
omeprazole	OMEPRAZOLE	Walgreen Company	b7972f17-4a63-4d78-a181-01ea6d7d3963	2024-03-04	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
foster and thrive omeprazole	OMEPRAZOLE	Strategic Sourcing Services LLC	836efc63-b633-497c-ab56-76bb495bd723	2024-02-20	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
equaline omeprazole	OMEPRAZOLE	United Natural Foods, Inc. dba UNFI	b6c87a6a-253a-4455-9b7d-62f506da592e	2023-08-02	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
omeprazole	OMEPRAZOLE	Walgreen Company	87cee50d-4c1e-473d-9d70-b1622f84aee1	2023-03-17	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032

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	Marketing end	Sample	Exclude flag	Status
49348-846-46	49348084646	14 BLISTER PACK in 1 CARTON (49348-846-46) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK	14 blister pack	2008-02-26	0000-00-00	No	No	Current
49348-846-61	49348084661	42 BLISTER PACK in 1 CARTON (49348-846-61) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK	42 blister pack	2008-02-26	0000-00-00	No	No	Current
49348-846-78	49348084678	28 BLISTER PACK in 1 CARTON (49348-846-78) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK	28 blister pack	2008-02-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
McKesson Omeprazole Delayed Release Tablets 20 mg Drug Facts	Strategic Sourcing Services LLC	2024-12-19	HUMAN OTC DRUG LABEL	8