Omeprazole

Product NDC: 0781-2234
11-digit product format: 007812234
Labeler code: 0781
Product ID: 0781-2234_fe6aa833-89e6-4679-a7b8-6600e92c1bed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA076515
Marketing category: ANDA
Marketing start: 2009-01-21
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: 2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076515-001	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2009-01-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076515-001	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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2009-01-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076515-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2009-01-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A076515-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076515-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076515-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076515-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076515-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076515-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076515-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076515-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076515-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076515-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076515-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076515-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076515-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076515-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076515-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076515-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076515-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076515-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076515-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076515-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076515-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076515-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076515-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076515-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076515-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076515-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076515-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076515-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076515-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076515-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076515-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076515-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076515-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076515-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076515-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076515-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076515-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076515-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076515-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076515-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Omeprazole
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
5a09ce48-7139-4fc7-9b6e-439459c8e866	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
873ef493-6b37-49d8-ac7f-bfca4117d2c1	Product name	5	20210607
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0781-2234-01	2020-03-09	These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
0781-2234-10	2020-03-09	These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
0781-2234-31	2020-03-09	These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
0781-2234-01	2020-01-31	These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
0781-2234-10	2020-01-31	These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
0781-2234-31	2020-01-31	These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0781-2234-01	Omeprazole	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	26
0781-2234-10	Omeprazole	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	26
0781-2234-31	Omeprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-2234-01	EA - Each	0781-2234	5fba6c57-0204-49b9-a00d-f7db698ab0a7	1	2012-07-24
0781-2234-10	EA - Each	0781-2234	90e62746-3817-4eff-a436-f1a7755fa385	1	2012-07-24
0781-2234-31	EA - Each	0781-2234	12e81638-2ed5-448b-af1b-e1755eaf1d09	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	14
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	14
ACETONE	INACTIVE INGREDIENT	1364PS73AF	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	14
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	14
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	14
CARRAGEENAN	INACTIVE INGREDIENT	5C69YCD2YJ	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	14
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	14
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	14
DIBUTYL SEBACATE	INACTIVE INGREDIENT	4W5IH7FLNY	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	14
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	14
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	14
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	14
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	14
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	14
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)	INACTIVE INGREDIENT	87Y6436BKR	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	14
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	14
POTASSIUM CHLORIDE	INACTIVE INGREDIENT	660YQ98I10	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	14
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	14
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	14
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	14
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	3
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	3
CARRAGEENAN	INACTIVE INGREDIENT	5C69YCD2YJ	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	3
DIBUTYL SEBACATE	INACTIVE INGREDIENT	4W5IH7FLNY	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	3
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	3
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)	INACTIVE INGREDIENT	87Y6436BKR	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	3
POTASSIUM CHLORIDE	INACTIVE INGREDIENT	660YQ98I10	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-2234	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]	25	Current NDC, Legacy NDC, 3 package rows	20231020_5a09ce48-7139-4fc7-9b6e-439459c8e866.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	Sandoz Inc	5a09ce48-7139-4fc7-9b6e-439459c8e866	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076515 application number: ANDA076515 ndc (product): 0781-2234

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
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	5a09ce48-7139-4fc7-9b6e-439459c8e866	26
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	5a09ce48-7139-4fc7-9b6e-439459c8e866	26
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	89691e50-c250-6c87-e053-2995a90a2705	2
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	89691e50-c250-6c87-e053-2995a90a2705	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-2234-01	00781223401	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2234-01)	2009-01-21	0000-00-00	No	No	Current
0781-2234-10	00781223410	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2234-10)	2009-01-21	0000-00-00	No	No	Current
0781-2234-31	00781223431	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2234-31)	2009-01-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole	Sandoz Inc	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	26
Omeprazole	REMEDYREPACK INC.	2022-07-13	HUMAN PRESCRIPTION DRUG LABEL	7
Omeprazole	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2020-07-23	HUMAN PRESCRIPTION DRUG LABEL	2
Omeprazole	Major Pharmaceuticals	2019-10-22	HUMAN PRESCRIPTION DRUG LABEL	5