Omeprazole

Product NDC: 60505-0145
11-digit product format: 605050145
Labeler code: 60505
Product ID: 60505-0145_8619e520-d106-4778-e92a-09b919b55c70
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Apotex Corp
Application: ANDA076048
Marketing category: ANDA
Marketing start: 2003-11-11
Marketing end: 2027-01-31
Substance: OMEPRAZOLE
Active strength: 10 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	60505-0145	60505-0145-0	D	Discontinued by firm	2026-08-17
excluded package	package	60505-0145	60505-0145-1	D	Discontinued by firm	2026-08-17
excluded package	package	60505-0145	60505-0145-3	D	Discontinued by firm	2026-08-17
excluded package	package	60505-0145	60505-0145-7	D	Discontinued by firm	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 1 · 36 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	60505-0145-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	60505-0145-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	60505-0145-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	60505-0145-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	60505-0145-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	60505-0145-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	60505-0145-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	60505-0145-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	60505-0145-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	60505-0145-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	60505-0145-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	60505-0145-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	60505-0145-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	60505-0145-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	60505-0145-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	60505-0145-7	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	60505-0145-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	60505-0145-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	60505-0145-7	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	60505-0145-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	60505-0145-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	60505-0145-7	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	60505-0145-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	60505-0145-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	60505-0145-7	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	60505-0145-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	60505-0145-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	60505-0145-7	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	60505-0145-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	60505-0145-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	60505-0145-7	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	60505-0145-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	60505-0145-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	60505-0145-7	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	60505-0145-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	60505-0145-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
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 · 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	A076048-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076048-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076048-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`caaa826d4ba7…`
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…`

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	A076048-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076048-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076048-003	AB	1	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Omeprazole

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMEPRAZOLE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198051	Internal RxNorm lookup
199119	Internal RxNorm lookup
200329	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
b83329ac-a65e-b3af-a3fb-c5a6c740e5e7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1	Product name	5	20210607
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60505-0145-0	Omeprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	35
60505-0145-1	Omeprazole	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	35
60505-0145-2	Omeprazole	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	35
60505-0145-3	Omeprazole	7 in 1 CARTON	CAPSULE, DELAYED RELEASE	7	35
60505-0145-3	Omeprazole	10 in 1 BLISTER PACK	CAPSULE, DELAYED RELEASE	10	35
60505-0145-7	Omeprazole	10 in 1 CARTON	CAPSULE, DELAYED RELEASE	10	35
60505-0145-7	Omeprazole	10 in 1 BLISTER PACK	CAPSULE, DELAYED RELEASE	10	35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-0145-0	EA - Each	60505-0145	75ce3b5d-8269-41ec-9c0f-023d1757c956	1	2012-07-24
60505-0145-1	EA - Each	60505-0145	9d84a9fb-3618-4057-98fe-763f7bfa48b3	1	2012-07-24
60505-0145-2	EA - Each	60505-0145	31a33844-de11-4a38-aef8-e675081b4075	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 [APOTEX CORP]	15
Omeprazole	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
Omeprazole	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-0145	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	35	Current NDC, Legacy NDC, 7 package rows	20240423_b83329ac-a65e-b3af-a3fb-c5a6c740e5e7.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 · 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 ndc (product): 60505-0145
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199119	omeprazole 10 MG Delayed Release Oral Capsule	PSN	b83329ac-a65e-b3af-a3fb-c5a6c740e5e7	35
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	b83329ac-a65e-b3af-a3fb-c5a6c740e5e7	35
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	b83329ac-a65e-b3af-a3fb-c5a6c740e5e7	35
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	b83329ac-a65e-b3af-a3fb-c5a6c740e5e7	35
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	b83329ac-a65e-b3af-a3fb-c5a6c740e5e7	35
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	b83329ac-a65e-b3af-a3fb-c5a6c740e5e7	35
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	b83329ac-a65e-b3af-a3fb-c5a6c740e5e7	35
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	b83329ac-a65e-b3af-a3fb-c5a6c740e5e7	35
199119	omeprazole 10 MG Delayed Release Oral Capsule	PSN	03ac077f-3873-4087-96d0-89049161dea9	7
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	03ac077f-3873-4087-96d0-89049161dea9	7
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	03ac077f-3873-4087-96d0-89049161dea9	7
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	03ac077f-3873-4087-96d0-89049161dea9	7
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	03ac077f-3873-4087-96d0-89049161dea9	7
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	03ac077f-3873-4087-96d0-89049161dea9	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-0145-0	60505014500	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0145-0)		2003-11-11	0000-00-00	No	No	Current
60505-0145-1	60505014501	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0145-1)		2003-11-11	0000-00-00	No	No	Current
60505-0145-2	60505014502	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0145-2)		2003-11-11	2027-01-31	No	No	Current
60505-0145-3	60505014503	7 BLISTER PACK in 1 CARTON (60505-0145-3) > 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK	7 blister pack	2003-11-11	0000-00-00	No	No	Current
60505-0145-7	60505014507	10 BLISTER PACK in 1 CARTON (60505-0145-7) > 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK	10 blister pack	2003-11-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole	Proficient Rx LP	2024-10-01	HUMAN PRESCRIPTION DRUG LABEL	7
Omeprazole	Apotex Corp \| Apotex Inc.	2024-04-22	HUMAN PRESCRIPTION DRUG LABEL	35