Omeprazole

Product NDC: 68382-412
11-digit product format: 683820412
Labeler code: 68382
Product ID: 68382-412_d0074baa-52cb-4039-9bd8-966a36ff70da
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
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 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
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 · 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	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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091352-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091352-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091352-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-11-19	`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	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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091352-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091352-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091352-001	AB	1	`8072bd15b7f6…`

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 · 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
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 ndc (product): 68382-412

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 · 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
9c22ceb2-2c34-43c3-9a35-2589c9078741	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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	SPL version
68382-412-01	Omeprazole	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	18
68382-412-05	Omeprazole	500 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	500	18
68382-412-06	Omeprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	18
68382-412-10	Omeprazole	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	18
68382-412-16	Omeprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-412-01	EA - Each	68382-412	cfbdfe30-df8d-41bb-98e1-0bde676fe509	1	2013-02-13
68382-412-05	EA - Each	68382-412	0c64066e-ac89-4484-b5fd-d926344cb24c	1	2015-04-03
68382-412-06	EA - Each	68382-412	12bfcb5f-0943-4964-a1bd-6a167300d4ca	1	2013-02-13
68382-412-10	EA - Each	68382-412	551a62c0-447d-4087-9ad9-36c878927405	1	2013-02-13
68382-412-16	EA - Each	68382-412	fd862998-fe4a-45f1-a084-a6bece7f1e45	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	5
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	5
ACETONE	INACTIVE INGREDIENT	1364PS73AF	OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	5
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	5
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	5
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	5
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)	INACTIVE INGREDIENT	8LDD2V82F5	OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	5
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	94255I6E2T	OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	5
SUCROSE	INACTIVE INGREDIENT	C151H8M554	OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	5
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-412	OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]	18	Current NDC, Legacy NDC, 5 package rows	20230513_9c22ceb2-2c34-43c3-9a35-2589c9078741.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
199119	omeprazole 10 MG Delayed Release Oral Capsule	PSN	9c22ceb2-2c34-43c3-9a35-2589c9078741	18
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	9c22ceb2-2c34-43c3-9a35-2589c9078741	18
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	9c22ceb2-2c34-43c3-9a35-2589c9078741	18
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	9c22ceb2-2c34-43c3-9a35-2589c9078741	18
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	9c22ceb2-2c34-43c3-9a35-2589c9078741	18
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	9c22ceb2-2c34-43c3-9a35-2589c9078741	18
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	9c22ceb2-2c34-43c3-9a35-2589c9078741	18
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	9c22ceb2-2c34-43c3-9a35-2589c9078741	18
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	9724601b-bb12-4eb2-bc2e-0532976bf5d1	9
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	9724601b-bb12-4eb2-bc2e-0532976bf5d1	9
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	9724601b-bb12-4eb2-bc2e-0532976bf5d1	9
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	1c99e189-93c0-4461-82c2-4521e6c4d514	8
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	1c99e189-93c0-4461-82c2-4521e6c4d514	8
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	1c99e189-93c0-4461-82c2-4521e6c4d514	8
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	0ef8d55f-6cae-4b58-844b-968d8e5b8c24	7
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	0ef8d55f-6cae-4b58-844b-968d8e5b8c24	7
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	0ef8d55f-6cae-4b58-844b-968d8e5b8c24	7
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	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-412-01	68382041201	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-412-01)	2012-11-23	0000-00-00	No	No	Current
68382-412-05	68382041205	500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-412-05)	2012-11-23	0000-00-00	No	No	Current
68382-412-06	68382041206	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-412-06)	2012-11-23	0000-00-00	No	No	Current
68382-412-10	68382041210	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-412-10)	2012-11-23	0000-00-00	No	No	Current
68382-412-16	68382041216	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-412-16)	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	A-S Medication Solutions	2024-07-24	HUMAN PRESCRIPTION DRUG LABEL	9
Omeprazole	A-S Medication Solutions	2024-02-27	HUMAN PRESCRIPTION DRUG LABEL	8
Omeprazole	A-S Medication Solutions	2024-02-27	HUMAN PRESCRIPTION DRUG LABEL	7
Omeprazole	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2023-05-11	HUMAN PRESCRIPTION DRUG LABEL	18