topcare omeprazole

Product NDC: 36800-601
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 (product): 36800-601
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

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

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
36800-601-55	36800060155	3 CARTON in 1 CARTON (36800-601-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK	3 carton	2018-04-02	0000-00-00	No	No	Current
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