omeprazole

Product NDC: 37808-401
11-digit product format: 378080401
Labeler code: 37808
Product ID: 37808-401_9cb203e7-86d0-4757-9a32-afd2038898a3
Type: HUMAN OTC DRUG
Nonproprietary name: Omeprazole
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: H E B
Application: NDA022032
Marketing category: NDA
Marketing start: 2015-04-03
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

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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022032-001	OMEPRAZOLE	20MG	TABLET, DELAYED RELEASE / ORAL	RLD, RS	2007-12-04	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022032-001	9023391	2025-08-16	Drug product	2015-06-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022032-001	12599565	2030-01-31	Drug product	2026-05-11	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: 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
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
491e3710-9a15-4b07-ae22-923bd1152ecc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
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
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
424daadb-95de-8ece-97f5-235e3f7f0001	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
37808-401-01	omeprazole	14 in 1 BOTTLE	TABLET, DELAYED RELEASE	14	5
37808-401-01	omeprazole	1 in 1 CARTON	TABLET, DELAYED RELEASE	1	5
37808-401-03	omeprazole	3 in 1 CARTON	TABLET, DELAYED RELEASE	3	5
37808-401-03	omeprazole	14 in 1 BOTTLE	TABLET, DELAYED RELEASE	14	5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H E B]	1
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H E B]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H E B]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H E B]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H E B]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H E B]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H E B]	1
MONOETHANOLAMINE	INACTIVE INGREDIENT	5KV86114PT	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H E B]	1
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H E B]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H E B]	1
SODIUM STEARATE	INACTIVE INGREDIENT	QU7E2XA9TG	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H E B]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H E B]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H E B]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H E B]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H E B]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H E B]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H E B]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-401	OMEPRAZOLE TABLET, DELAYED RELEASE [H E B]	5	Current NDC, Legacy NDC, 4 package rows	20250123_491e3710-9a15-4b07-ae22-923bd1152ecc.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 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Berkley and Jensen Omeprazole	OMEPRAZOLE	BJWC	f74752a8-a686-4c7d-91ad-8c87c4596a7a	2026-05-21	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
care one omeprazole	OMEPRAZOLE	American Sales Company	db2d75ea-5924-4b7f-a92d-d4847a010d52	2026-04-17	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
omeprazole	OMEPRAZOLE	Rite Aid Corporation	ee853401-b641-4dab-b708-29424c2d0b79	2026-03-25	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
omeprazole	OMEPRAZOLE	HyVee Inc	a5df7dac-00f4-4d97-9586-cde3055890ac	2026-02-04	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
omeprazole	OMEPRAZOLE	HyVee Inc	cf9919e6-a839-4bad-a007-80d5bf6f81db	2026-01-30	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
good neighbor pharmacy omeprazole	OMEPRAZOLE	Amerisource Bergen	f9aab207-d309-49b5-b941-c2912b186583	2025-12-21	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
omeprazole	OMEPRAZOLE	Kroger Company	015b1c8f-9d5b-4afc-a55c-1a731b5fc72a	2025-12-08	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
dg health omeprazole	OMEPRAZOLE	Dolgencorp, LLC	326bf21c-fad4-473e-9e7f-797319d4353a	2025-09-02	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
omeprazole	OMEPRAZOLE	Kroger Company	da18d91c-5fe9-44d4-9d6f-602900af3f08	2025-06-04	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
careone omeprazole	OMEPRAZOLE	Retail Business Services, LLC	063cfad8-3ca6-4b72-a4c9-512b8047bae3	2025-04-17	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
leader omeprazole	OMEPRAZOLE	Cardinal Health 110, LLC. dba Leader	19beab17-ca25-4be3-bada-20a2e9aa26b5	2025-04-16	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
rugby omeprazole	OMEPRAZOLE	Rugby Laboratories	61952807-f38d-4e7a-8646-a8ec85d7fb37	2025-04-15	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
careone omeprazole	OMEPRAZOLE	American Sales Company	a5ec923a-dbc7-43e0-b3b8-f61dcaa6765d	2025-04-14	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
signature care omeprazole	OMEPRAZOLE	Safeway	85ece978-3cfb-4c09-bf0f-3217fda8e7d4	2025-04-14	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
equate omeprazole	OMEPRAZOLE	WALMART INC.	dcfe8e94-9c88-464e-9a80-3baa9c4755d9	2025-03-27	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
equate omeprazole	OMEPRAZOLE	Wal-Mart Stores Inc	504b8282-d93f-454f-9f93-84cb8a9105d7	2025-03-25	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
omeprazole	OMEPRAZOLE	H E B	501d80c0-68ee-4fd9-bc56-0b214dbf72b5	2025-02-27	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
omeprazole	OMEPRAZOLE	Padagis Israel Pharmaceuticals Ltd	cb47354c-297b-4dc2-85af-242acc967b56	2025-02-06	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
Signature Care Omeprazole	OMEPRAZOLE	Safeway	6361a492-782f-4608-a20f-1bd86afbd864	2025-02-06	Warnings	Exact identifier application applno (NDA): 022032 application number: NDA022032
omeprazole	OMEPRAZOLE	H E B	5ceaec04-3ca3-4c7c-9184-51a42686a595	2025-02-05	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
402014	omeprazole 20 MG Delayed Release Oral Tablet	PSN	491e3710-9a15-4b07-ae22-923bd1152ecc	5
402014	omeprazole 20 MG Delayed Release Oral Tablet	SCD	491e3710-9a15-4b07-ae22-923bd1152ecc	5
402014	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet	SY	491e3710-9a15-4b07-ae22-923bd1152ecc	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37808-401-01	37808040101	1 BOTTLE in 1 CARTON (37808-401-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE	1 bottle	2015-04-03	0000-00-00	No	No	Current
37808-401-03	37808040103	3 BOTTLE in 1 CARTON (37808-401-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE	3 bottle	2015-04-03	0000-00-00	No	No	Current