Omeprazole

Product NDC: 0904-6917
11-digit product format: 009046917
Labeler code: 0904
Product ID: 0904-6917_54091ab1-10e5-4a5c-8abc-e58d24d24168
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA091352
Marketing category: ANDA
Marketing start: 2012-11-23
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 42.

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
A091352-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19
A091352-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19
A091352-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091352-001	AB
A091352-002	AB
A091352-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091352-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091352-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091352-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091352-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091352-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091352-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091352-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091352-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091352-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091352-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091352-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091352-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091352-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091352-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091352-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091352-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091352-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091352-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091352-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091352-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091352-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091352-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091352-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091352-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091352-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091352-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091352-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091352-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091352-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091352-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091352-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091352-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091352-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091352-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091352-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091352-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091352-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091352-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091352-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091352-001	AB	1	`1e350fbaab3a…`

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
198051	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
afda9d2c-b141-4c32-a5b4-e850974b30a3	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-6917-61	Omeprazole	100 in 1 CARTON	CAPSULE, DELAYED RELEASE	100		6
0904-6917-61	Omeprazole	1 in 1 BLISTER PACK	CAPSULE, DELAYED RELEASE	1		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6917-61	EA - Each	0904-6917	f96b5e26-c355-488a-a438-c947f45e8beb	1	2020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6917	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	5	Current NDC, Legacy NDC, 2 package rows	20240518_afda9d2c-b141-4c32-a5b4-e850974b30a3.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	Major Pharmaceuticals	afda9d2c-b141-4c32-a5b4-e850974b30a3	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091352 application number: ANDA091352 ndc (product): 0904-6917
Omeprazole	OMEPRAZOLE	Cardinal Health 107, LLC	fbd71fd8-3f36-46a1-bc76-53f6820d42a2	2025-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091352 application number: ANDA091352
Omeprazole	OMEPRAZOLE	Zydus Lifesciences Limited	2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca2	2024-12-03		Exact identifier application applno (ANDA): 091352 application number: ANDA091352
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	9724601b-bb12-4eb2-bc2e-0532976bf5d1	2024-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091352 application number: ANDA091352
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	0ef8d55f-6cae-4b58-844b-968d8e5b8c24	2024-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091352 application number: ANDA091352
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	1c99e189-93c0-4461-82c2-4521e6c4d514	2024-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091352 application number: ANDA091352
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	39e3b45a-8e9b-49d6-976a-6668f4e27649	2023-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091352 application number: ANDA091352
Omeprazole	OMEPRAZOLE	Zydus Pharmaceuticals USA Inc.	9c22ceb2-2c34-43c3-9a35-2589c9078741	2023-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091352 application number: ANDA091352

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
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	fbd71fd8-3f36-46a1-bc76-53f6820d42a2	8
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	fbd71fd8-3f36-46a1-bc76-53f6820d42a2	8
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	fbd71fd8-3f36-46a1-bc76-53f6820d42a2	8
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	afda9d2c-b141-4c32-a5b4-e850974b30a3	6
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	afda9d2c-b141-4c32-a5b4-e850974b30a3	6
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	afda9d2c-b141-4c32-a5b4-e850974b30a3	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6917-61	00904691761	100 BLISTER PACK in 1 CARTON (0904-6917-61) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK	100 blister pack	2012-11-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole	Major Pharmaceuticals	2025-09-19	HUMAN PRESCRIPTION DRUG LABEL	6
Omeprazole	Cardinal Health 107, LLC	2025-06-05	HUMAN PRESCRIPTION DRUG LABEL	8