Omeprazole

Product NDC: 59651-003
Requested package NDC: 59651-003-22
11-digit product format: 596510003
Labeler code: 59651
Product ID: 59651-003_4cc78adf-d6a3-47b6-bc25-9d3f28d2a27a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA203270
Marketing category: ANDA
Marketing start: 2015-08-19
Substance: OMEPRAZOLE
Active strength: 40 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
unfinished package	package	59651-003	59651-003-22	UNFINISHED	Active or certified unfinished drug listing		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 · 21 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 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	`5b2001dcd8f5…`	`54b53d4dc9e4…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203270-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19
A203270-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19
A203270-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203270-001	AB
A203270-002	AB
A203270-003	AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203270-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203270-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203270-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203270-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203270-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203270-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203270-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203270-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203270-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203270-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203270-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203270-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203270-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203270-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203270-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203270-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203270-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203270-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203270-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203270-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203270-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203270-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203270-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203270-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203270-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203270-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203270-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203270-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203270-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203270-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203270-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203270-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203270-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203270-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203270-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203270-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203270-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203270-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203270-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203270-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Omeprazole
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMEPRAZOLE	40 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198051	Internal RxNorm lookup
199119	Internal RxNorm lookup
200329	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
934601b6-fbba-43c4-a8ef-7a7dfe9f9a51	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
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
59651-003-01	Omeprazole	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	19
59651-003-03	Omeprazole	3 in 1 CARTON	CAPSULE, DELAYED RELEASE	3	19
59651-003-05	Omeprazole	500 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	500	19
59651-003-10	Omeprazole	10 in 1 BLISTER PACK	CAPSULE, DELAYED RELEASE	10	19
59651-003-30	Omeprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	19
59651-003-78	Omeprazole	10 in 1 CARTON	CAPSULE, DELAYED RELEASE	10	19
59651-003-90	Omeprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	19
59651-003-99	Omeprazole	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59651-003-05	EA - Each	59651-003	66a41412-7ee6-4328-87db-8c0c66c6afa7	1	2018-07-03
59651-003-30	EA - Each	59651-003	c8e7f726-233b-4482-808f-26b0608b638d	1	2019-03-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	1
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	1
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	1
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	94255I6E2T	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59651-003	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	19	Current NDC, Legacy NDC, 8 package rows	20240618_934601b6-fbba-43c4-a8ef-7a7dfe9f9a51.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	QPharma Inc	50115204-74f7-17c1-e063-6394a90ab665	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Preferred Phharmaceuticals Inc.	319d990e-161b-4c16-b026-f55c413c7e8f	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Proficient Rx LP	61eab342-61fd-471f-8f70-95f9cbca0097	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	c1276463-7357-45b5-9f7e-8d3c4a550ff4	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	df1a4294-3893-4a11-b4d5-f3536678087e	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	af707c0a-5193-3f83-e053-2995a90a78ef	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Northwind Health Company, LLC	10a3fbc9-00c6-ad83-e063-6294a90ae1ad	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Northwind Health Company, LLC	f3038133-8bb2-044e-e053-2995a90a6e7d	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	QPharma, Inc.	f5dd5d63-1376-1ff7-e053-2a95a90a1d94	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	40b4e1b6-f64d-44d5-bfc2-0cb8f78d9e67	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	064b1418-0f42-4b18-9dee-cda40c5e1fca	2024-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	c311c1b9-8ec2-4ac0-baa2-a5063fba2d80	2024-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Rising Pharma Holdings, Inc.	a1b1c61b-d4fe-433d-ad31-0b11758976fa	2024-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	fe7d3352-d53f-4046-92ed-1eb5c917fbee	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	8d925ca6-83f1-4263-8218-4bf7cc8ceb39	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	9378c870-f2cc-4a60-b0fd-08a4d43857bc	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Aurobindo Pharma Limited	934601b6-fbba-43c4-a8ef-7a7dfe9f9a51	2024-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270 ndc (product): 59651-003

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
199119	omeprazole 10 MG Delayed Release Oral Capsule	PSN	934601b6-fbba-43c4-a8ef-7a7dfe9f9a51	19
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	934601b6-fbba-43c4-a8ef-7a7dfe9f9a51	19
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	934601b6-fbba-43c4-a8ef-7a7dfe9f9a51	19
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	934601b6-fbba-43c4-a8ef-7a7dfe9f9a51	19
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	934601b6-fbba-43c4-a8ef-7a7dfe9f9a51	19
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	934601b6-fbba-43c4-a8ef-7a7dfe9f9a51	19
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	934601b6-fbba-43c4-a8ef-7a7dfe9f9a51	19
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	934601b6-fbba-43c4-a8ef-7a7dfe9f9a51	19
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	404599a8-5640-420c-8d69-8e07be5c57dc	3
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	404599a8-5640-420c-8d69-8e07be5c57dc	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
59651-003-22	59651000322	2000 CAPSULE, DELAYED RELEASE in 1 BAG (59651-003-22)	19-AUG-15	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole	Aurobindo Pharma Limited	2024-06-17	Human Prescription Drug Label	19
Omeprazole	A-S Medication Solutions	2019-03-25	Human Prescription Drug Label	3