Omeprazole

Product NDC: 0904-5684
11-digit product format: 009045684
Labeler code: 0904
Product ID: 0904-5684_71b6e1f9-5b2c-4540-b582-75dcc2793abd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA076048
Marketing category: ANDA
Marketing start: 2008-02-28
Marketing end: 0000-00-00
Substance: OMEPRAZOLE
Active strength: 20 mg/1
Pharmacologic classes: Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0904-5684		D	Discontinued by firm		2026-08-07
excluded package	package	0904-5684	0904-5684-61	D	Discontinued by firm		2026-08-07

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0904-5684-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0904-5684-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0904-5684-61	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0904-5684-61	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0904-5684-61	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0904-5684-61	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0904-5684-61	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0904-5684-61	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0904-5684-61	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0904-5684-61	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0904-5684-61	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0904-5684-61	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A076048-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22
A076048-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22
A076048-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076048-001	AB
A076048-002	AB
A076048-003	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	A076048-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076048-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076048-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076048-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076048-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076048-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076048-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076048-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076048-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076048-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076048-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076048-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076048-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076048-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076048-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076048-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076048-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076048-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076048-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076048-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076048-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076048-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076048-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076048-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076048-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076048-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076048-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076048-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076048-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076048-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076048-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076048-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076048-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076048-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076048-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076048-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076048-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076048-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076048-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076048-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`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	A076048-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076048-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076048-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076048-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076048-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076048-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076048-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076048-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076048-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076048-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076048-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076048-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076048-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076048-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076048-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076048-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076048-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076048-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076048-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076048-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076048-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076048-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076048-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076048-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076048-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076048-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076048-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076048-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076048-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076048-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076048-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076048-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076048-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076048-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076048-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076048-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076048-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076048-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076048-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076048-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5684-61	EA - Each	0904-5684	1a8b8263-8703-4811-aa7c-856b79162e59	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 [CARDINAL HEALTH]	3
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	1249c42d-6358-48b3-8fe0-10333c7f501d	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076048 application number: ANDA076048
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	44349466-73ea-4053-8ff6-5b4b7372c9cd	2024-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076048 application number: ANDA076048
Omeprazole	OMEPRAZOLE	Proficient Rx LP	03ac077f-3873-4087-96d0-89049161dea9	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076048 application number: ANDA076048
Omeprazole	OMEPRAZOLE	Proficient Rx LP	253451a6-02a9-4b27-aed7-f3dbc2e09682	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076048 application number: ANDA076048
Omeprazole	OMEPRAZOLE	Apotex Corp	b83329ac-a65e-b3af-a3fb-c5a6c740e5e7	2024-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076048 application number: ANDA076048
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	a0dc4ffa-db18-4871-9d36-51d02e3b2bd9	2019-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076048 application number: ANDA076048

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
KG60484QX9	OMEPRAZOLE	73590-58-6	OMEPRAZOLE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-5684-61	00904568461	10 BLISTER PACK in 1 CARTON (0904-5684-61) > 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK	10 blister pack	2008-02-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole	Cardinal Health	2020-06-03	HUMAN PRESCRIPTION DRUG LABEL	7
Omeprazole	Major Pharmaceuticals	2019-10-22	HUMAN PRESCRIPTION DRUG LABEL	4