Omeprazole

Product NDC: 21695-098
11-digit product format: 216950098
Labeler code: 21695
Product ID: 21695-098_b6939539-2d45-4ea0-9744-72d7691e331f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Rebel Distributors Corp.
Application: ANDA075410
Marketing category: ANDA
Marketing start: 2002-11-04
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: E
Listing certified through: 2017-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-098		I	Inactivated by FDA	2026-08-17
excluded package	package	21695-098	21695-098-07	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-098	21695-098-10	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-098	21695-098-14	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-098	21695-098-15	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-098	21695-098-30	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-098	21695-098-60	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-098	21695-098-72	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-098	21695-098-90	I	Inactivated by FDA	2026-08-17

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 4 · 198 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	21695-098-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-098-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-098-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-098-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-098-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-098-72	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-098-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-098-90	`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	21695-098-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-098-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-098-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-098-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-098-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-098-72	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-098-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-098-90	`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	21695-098-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-098-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-098-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-098-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-098-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-098-72	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-098-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-098-90	`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	21695-098-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-098-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-098-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-098-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-098-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-098-72	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-098-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-098-90	`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	21695-098-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-098-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-098-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-098-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-098-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-098-72	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-098-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-098-90	`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	21695-098-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-098-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-098-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-098-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-098-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-098-72	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-098-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-098-90	`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	21695-098-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-098-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-098-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-098-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-098-07	`302b2466d912…`	`e7b80fea0513…`

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
A075410-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01
A075410-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01
A075410-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075410-001	AB
A075410-002	AB
A075410-003	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	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`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	A075410-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075410-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075410-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075410-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075410-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075410-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075410-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075410-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075410-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075410-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075410-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075410-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075410-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075410-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075410-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075410-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075410-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075410-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075410-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075410-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075410-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075410-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075410-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075410-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075410-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075410-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075410-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075410-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075410-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075410-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075410-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075410-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075410-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075410-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075410-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075410-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075410-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075410-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075410-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075410-001	AB	1	`1e350fbaab3a…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
21695-098-07	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. Initial U.S. Approval: 2002
21695-098-10	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. Initial U.S. Approval: 2002
21695-098-14	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. Initial U.S. Approval: 2002
21695-098-15	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. Initial U.S. Approval: 2002
21695-098-30	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. Initial U.S. Approval: 2002
21695-098-60	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. Initial U.S. Approval: 2002
21695-098-72	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. Initial U.S. Approval: 2002
21695-098-90	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. Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-098-07	Omeprazole	07 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	07	1
21695-098-10	Omeprazole	10 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	10	1
21695-098-14	Omeprazole	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	1
21695-098-15	Omeprazole	15 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	15	1
21695-098-30	Omeprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	1
21695-098-60	Omeprazole	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	60	1
21695-098-72	Omeprazole	120 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	120	1
21695-098-90	Omeprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-098-07	EA - Each	21695-098	b4443265-fda8-4609-9ecf-d5dd7b4c4dae	1	2012-07-24
21695-098-10	EA - Each	21695-098	98aff234-e2f4-49a0-828d-ba4bb2ea4e56	1	2012-07-24
21695-098-14	EA - Each	21695-098	cab110d6-a511-4903-979b-e043b5ef8664	1	2012-07-24
21695-098-15	EA - Each	21695-098	825a8c41-5c45-4da8-9997-a5913a070a4c	1	2012-07-24
21695-098-30	EA - Each	21695-098	83a465e0-efec-4bca-90c3-33c79e42ea4e	1	2012-07-24
21695-098-60	EA - Each	21695-098	3e1c272d-6c11-49ee-973a-d08f110dddef	1	2012-07-24
21695-098-72	EA - Each	21695-098	ad972fe0-d718-4562-80d3-36e1b52a5166	1	2012-07-24
21695-098-90	EA - Each	21695-098	f4d3a1d7-3be0-4535-91d1-856baff75d45	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 [REBEL DISTRIBUTORS CORP.]	1
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
GLYCERYL BEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-098	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]	1	Legacy NDC, 8 package rows	20100202_d58c0b66-475f-46b3-949d-cda5343e7239.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	Chartwell RX, LLC	10f5502a-2e63-4f2a-a3ba-ddc5bd403051	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	PD-Rx Pharmaceuticals, Inc.	ed9895ae-3d18-434c-8b56-47bccdc8fe6d	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	ad675ef6-5377-b9f2-e053-2995a90a06e9	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	55a1fb3c-f040-2e39-e054-00144ff8d46c	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	8991d464-7abc-4350-e053-2995a90a4ea7	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	1318a1c1-222d-471a-92d6-3632c82fb999	2024-05-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	18f5a7cc-40d8-4aeb-a601-47bc9024f130	2024-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	Lannett Company, Inc.	92201fb1-4570-42db-8da3-3b8c0e291d32	2023-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	Proficient Rx LP	9786b04f-f827-460b-91bc-c0ac967f95dd	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	4b188d97-f1b3-468d-9818-b8333bf24b5a	2020-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410

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	d58c0b66-475f-46b3-949d-cda5343e7239	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	d58c0b66-475f-46b3-949d-cda5343e7239	1
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	d58c0b66-475f-46b3-949d-cda5343e7239	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	d58c0b66-475f-46b3-949d-cda5343e7239	1
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	d58c0b66-475f-46b3-949d-cda5343e7239	1
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	d58c0b66-475f-46b3-949d-cda5343e7239	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-098-07	21695009807	07 in 1 BOTTLE	Historical
21695-098-10	21695009810	10 in 1 BOTTLE	Historical
21695-098-14	21695009814	14 in 1 BOTTLE	Historical
21695-098-15	21695009815	15 in 1 BOTTLE	Historical
21695-098-30	21695009830	30 in 1 BOTTLE	Historical
21695-098-60	21695009860	60 in 1 BOTTLE	Historical
21695-098-72	21695009872	120 in 1 BOTTLE	Historical
21695-098-90	21695009890	90 in 1 BOTTLE	Historical