topcare omeprazole

Product NDC: 36800-601
Requested package NDC: 36800-601-74
11-digit product format: 368000601
Labeler code: 36800
Product ID: 36800-601_0edd49e4-cf9e-42db-8bbb-78ce370ac480
Type: HUMAN OTC DRUG
Nonproprietary name: omeprazole
Dosage form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route: ORAL
Labeler: Topco Associates LLC
Application: NDA209400
Marketing category: NDA
Marketing start: 2018-04-02
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	36800-601	36800-601-74	D	Discontinued by firm		2026-08-03

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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`

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
N209400-001	OMEPRAZOLE	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		RLD, RS	2017-07-05

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209400-001	10076494	2036-12-08		Drug product	2018-09-18
N209400-001	10835488	2036-12-08		Drug product	2020-11-23

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD	2017-07-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD	2017-07-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD	2017-07-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD	2017-07-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD	2017-07-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD	2017-07-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD	2017-07-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD	2017-07-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD	2017-07-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD	2017-07-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209400-001	OMEPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	RLD, RS	2017-07-05	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 77 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209400-001	10835488	2036-12-08	Drug product	2020-11-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209400-001	10076494	2036-12-08	Drug product	2018-09-18	`87673890dc5c…`

Additional Listing Data#

Finished product: Yes
Brand name base: topcare 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
2003656	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
436c5ea1-c5ee-481f-803d-439f65873b1c	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
36800-601-55	topcare omeprazole	3 in 1 CARTON	TABLET, ORALLY DISINTEGRATING, D	3	5
36800-601-55	topcare omeprazole	14 in 1 CARTON	TABLET, ORALLY DISINTEGRATING, D	14	5
36800-601-74	topcare omeprazole	1 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING, D	1	5
36800-601-74	topcare omeprazole	14 in 1 CARTON	TABLET, ORALLY DISINTEGRATING, D	14	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-601-55	EA - Each	36800-601	9bd49514-f86c-4532-a343-c4571a1c90dc	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-601	TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [TOPCO ASSOCIATES LLC]	5	Current NDC, Legacy NDC, 4 package rows	20250205_436c5ea1-c5ee-481f-803d-439f65873b1c.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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
careone omeprazole	OMEPRAZOLE	American Sales Company	5b88717a-e90c-4e74-ae2a-29270e14a3cc	2026-07-08	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
omeprazole	OMEPRAZOLE	Rite Aid Corporation	6919399e-f112-4274-b4de-df0b4c391e63	2026-06-03	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
omeprazole	OMEPRAZOLE	HyVee Inc	fd22d4df-9679-4c2d-9bc4-3619288fb4cc	2026-02-01	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
omeprazole	OMEPRAZOLE	Kroger Company	083841e8-482d-4e5b-90ab-1139b576d691	2025-03-31	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
good neighbor pharmacy omeprazole	OMEPRAZOLE	Amerisource Bergen	54fd9f84-9c67-4846-b79d-eb9e6720a315	2025-03-31	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
Signature Care Omeprazole	OMEPRAZOLE	Safeway	c76c4235-92d4-4384-8ddc-ceed0b928c48	2025-03-31	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
berkley and jensen omeprazole	OMEPRAZOLE	BJWC	1729c60d-3475-45cd-b192-f88438403d1a	2025-03-06	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
Omeprazole	OMEPRAZOLE	CVS Pharmacy	01bde9ca-0114-426d-8188-c55aefaa0961	2025-03-05	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
topcare omeprazole	OMEPRAZOLE	Topco Associates LLC	436c5ea1-c5ee-481f-803d-439f65873b1c	2025-01-31	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400 ndc (package): 36800-601-74 ndc (product): 36800-601 ndc11 (package): 36800060174
up and up omeprazole	OMEPRAZOLE	Target Corporation	8f2eb5e8-80f2-4c40-a8ad-e1d9c10d0c56	2025-01-31	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
DG health omperazole	OMEPRAZOLE	Dolgencorp Inc	99fdfeed-6828-4bf6-bb81-cd29a4ec610b	2025-01-31	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
omeprazole	OMEPRAZOLE	H E B	344b5548-e5c0-45bf-bc3f-73af50bd5913	2025-01-30	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
Basic Care Omeprazole	OMEPRAZOLE	Amazon.com Services LLC	87a2aa9b-c681-41c7-8a59-b359efd443cb	2025-01-22	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
good sense omeprazole	OMEPRAZOLE	L. Perrigo Company	dcd93796-8904-415d-a379-c4ea590cf544	2025-01-22	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
omeprazole	OMEPRAZOLE	Walgreen Company	064f048c-eddd-4370-9ee4-706f9f00c8d2	2025-01-22	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
Leader Omeprazole	OMEPRAZOLE	Cardinal Health 110, LLC. dba Leader	b2dd3c63-3875-4a9b-9b78-b5b3eba2aa1a	2024-11-26	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
Omeprazole	OMEPRAZOLE	Meijer Distribution Inc	d54e1097-bd56-4371-8e59-8ceab1a5e824	2024-07-12	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400
equaline omeprazole	OMEPRAZOLE	United Natural Foods, Inc. dba UNFI	78743f3b-257e-49df-98cd-6cc0e1b4e370	2023-08-16	Warnings	Exact identifier application applno (NDA): 209400 application number: NDA209400

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
2003656	omeprazole 20 MG Delayed Release Disintegrating Oral Tablet	PSN	436c5ea1-c5ee-481f-803d-439f65873b1c	5
2003656	omeprazole 20 MG Disintegrating Oral Tablet	SCD	436c5ea1-c5ee-481f-803d-439f65873b1c	5
2003656	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Disintegrating Oral Tablet	SY	436c5ea1-c5ee-481f-803d-439f65873b1c	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-601-74	36800060174	14 BLISTER PACK in 1 CARTON (36800-601-74) > 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK	14 blister pack	2018-04-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Omeprazole Drug Facts	Topco Associates LLC	2025-01-31	HUMAN OTC DRUG LABEL	5