Omeprazole

Product NDC: 49999-265
11-digit product format: 499990265
Labeler code: 49999
Product ID: 49999-265_7be9407c-cd50-4b34-8277-c96a8db74e5a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Quality Care Products, LLC
Application: ANDA075576
Marketing category: ANDA
Marketing start: 2010-10-13
Marketing end: 2027-01-31
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
Current FDA listing: Yes

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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	49999-265	49999-265-00	D	Discontinued by firm	2026-09-14
excluded package	package	49999-265	49999-265-01	D	Discontinued by firm	2026-09-14
excluded package	package	49999-265	49999-265-14	D	Discontinued by firm	2026-09-14
excluded package	package	49999-265	49999-265-15	D	Discontinued by firm	2026-09-14
excluded package	package	49999-265	49999-265-28	D	Discontinued by firm	2026-09-14

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 · 57 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	49999-265-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	49999-265-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	49999-265-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	49999-265-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	49999-265-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	49999-265-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	49999-265-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	49999-265-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	49999-265-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	49999-265-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	49999-265-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	49999-265-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	49999-265-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	49999-265-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	49999-265-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	49999-265-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	49999-265-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	49999-265-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	49999-265-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	49999-265-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	49999-265-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	49999-265-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	49999-265-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	49999-265-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	49999-265-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	49999-265-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	49999-265-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	49999-265-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	49999-265-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	49999-265-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	49999-265-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	49999-265-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	49999-265-00	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	49999-265-28	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	49999-265-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	49999-265-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	49999-265-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	49999-265-00	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	49999-265-28	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	49999-265-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	49999-265-14	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	49999-265-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	49999-265-00	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	49999-265-28	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	49999-265-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	49999-265-28	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	49999-265-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	49999-265-00	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	49999-265-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	49999-265-28	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	49999-265-15	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	49999-265-00	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	49999-265-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	49999-265-28	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	49999-265-15	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	49999-265-00	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	49999-265-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075576-001	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21
A075576-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22
A075576-003	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075576-001	AB
A075576-002	AB
A075576-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075576-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075576-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075576-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075576-002	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	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075576-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075576-002	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	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075576-002	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	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075576-002	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	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075576-002	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	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075576-002	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	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075576-002	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	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075576-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075576-002	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	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075576-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075576-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075576-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075576-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075576-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075576-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075576-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075576-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075576-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075576-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075576-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075576-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075576-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075576-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075576-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075576-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075576-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075576-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075576-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075576-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075576-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075576-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075576-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075576-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075576-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075576-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075576-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075576-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075576-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075576-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075576-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075576-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075576-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075576-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075576-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075576-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075576-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075576-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075576-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075576-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Omeprazole

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMEPRAZOLE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
KG60484QX9	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198051	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
581d1c3d-457a-41f2-8db0-5b6219cdcb09	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1	Product name	5	20210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49999-265-00	Omeprazole	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	339005
49999-265-01	Omeprazole	120 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	120	339005
49999-265-14	Omeprazole	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	339005
49999-265-15	Omeprazole	15 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	15	339005
49999-265-28	Omeprazole	28 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	28	339005
49999-265-30	Omeprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	339005
49999-265-60	Omeprazole	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	60	339005
49999-265-90	Omeprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	339005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49999-265-00	EA - Each	49999-265	1c7309c6-fdf6-4a90-adc8-aef6254003c4	1	2012-07-24
49999-265-01	EA - Each	49999-265	4cc9238b-2db9-4c0a-91c0-5f26ec91ae64	1	2017-04-05
49999-265-14	EA - Each	49999-265	ae25af7c-6763-4513-807f-f70c40fb42d1	1	2017-04-05
49999-265-15	EA - Each	49999-265	4ec23ce8-91ff-4e40-a4e5-3569b0700a59	1	2012-07-24
49999-265-28	EA - Each	49999-265	cd97e11d-680b-4d19-a3ab-7f3ec2ed2243	1	2012-07-24
49999-265-30	EA - Each	49999-265	852d3237-8be2-41d3-b0ff-f67f6a0f8590	1	2012-07-24
49999-265-60	EA - Each	49999-265	60c8ea27-0866-42fc-a195-472f7404c7f9	1	2012-07-24
49999-265-90	EA - Each	49999-265	6b56f3f3-6085-4aac-ace0-c6cdcaa30f08	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379
MEGLUMINE	INACTIVE INGREDIENT	6HG8UB2MUY	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379
POLOXAMER 124	INACTIVE INGREDIENT	1S66E28KXA	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3379

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49999-265	OMEPRAZOLE CAPSULE, DELAYED RELEASE [QUALITY CARE PRODUCTS, LLC]	339005	Current NDC, Legacy NDC, 8 package rows	20241220_581d1c3d-457a-41f2-8db0-5b6219cdcb09.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	St. Mary's Medical Park Pharmacy	1eb57c13-25ed-70bc-e063-6294a90afdac	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576
Omeprazole	OMEPRAZOLE	Northwind Health Company, LLC	aae3bf9f-5d05-889f-e053-2995a90a5ff2	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576
Omeprazole	OMEPRAZOLE	QPharma, Inc.	f5dcf0b2-4fa2-023a-e053-2995a90a183a	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576
Omeprazole	OMEPRAZOLE	Quallent Pharmaceuticals Health LLC	665e9877-85ac-fdb6-54ac-1c47941ceab8	2025-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576
Omeprazole	OMEPRAZOLE	PD-Rx Pharmaceuticals, Inc.	e235ef89-3592-4ca1-8c13-d7ce84b1001c	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576
Omeprazole DR	OMEPRAZOLE	Advanced Rx of Tennessee, LLC	af85e324-ef9f-196c-e053-2995a90a384e	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576
Omeprazole	OMEPRAZOLE	Quality Care Products, LLC	581d1c3d-457a-41f2-8db0-5b6219cdcb09	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576 ndc (product): 49999-265
Omeprazole	OMEPRAZOLE	Proficient Rx LP	f0f61a89-700d-481d-9255-6f9a9afa7025	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576
Omeprazole	OMEPRAZOLE	Advanced Rx of Tennessee, LLC	1d4ecc1e-5180-f75e-e063-6394a90a51a6	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	e1f20429-cfaa-420b-a65a-271be37eb799	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576
Omeprazole	OMEPRAZOLE	Dr. Reddy's Laboratories Limited	72fb11b6-b08c-2f02-d82b-f60f52394903	2024-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	b129fe93-c8a2-4ae8-ad1b-8f9ae5779b68	2023-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576
Omeprazole	OMEPRAZOLE	NorthStar Rx LLC	c5af5f4b-17be-7245-b281-f27c87831242	2023-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	581d1c3d-457a-41f2-8db0-5b6219cdcb09	339005
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	581d1c3d-457a-41f2-8db0-5b6219cdcb09	339005
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	581d1c3d-457a-41f2-8db0-5b6219cdcb09	339005

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49999-265-00	49999026500	100 in 1 BOTTLE					Historical
49999-265-01	49999026501	120 in 1 BOTTLE					Historical
49999-265-14	49999026514	14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49999-265-14)	2013-11-01	0000-00-00	No	No	Current
49999-265-15	49999026515	15 in 1 BOTTLE					Historical
49999-265-28	49999026528	28 in 1 BOTTLE					Historical
49999-265-30	49999026530	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49999-265-30)	2013-11-01	2027-01-31	No	No	Current
49999-265-60	49999026560	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49999-265-60)	2013-11-01	2027-01-31	No	No	Current
49999-265-90	49999026590	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49999-265-90)	2013-11-01	2027-01-31	No	No	Current