Omeprazole

Product NDC: 67296-1367
Requested package NDC: 67296-1367-3
11-digit product format: 672961367
Labeler code: 67296
Product ID: 67296-1367_d61b683b-6fc9-a48f-e053-2995a90a6df4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA203270
Marketing category: ANDA
Marketing start: 2015-08-19
Marketing end: 0000-00-00
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
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67296-1367	67296-1367-3	I	Inactivated by FDA		2026-10-05

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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A203270-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19
A203270-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19
A203270-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203270-001	AB
A203270-002	AB
A203270-003	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	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203270-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203270-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203270-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2015-08-19	`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	A203270-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203270-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203270-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203270-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203270-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203270-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203270-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203270-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203270-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203270-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203270-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203270-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203270-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203270-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203270-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203270-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203270-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203270-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203270-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203270-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203270-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203270-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203270-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203270-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203270-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203270-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203270-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203270-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203270-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203270-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203270-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203270-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203270-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203270-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203270-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203270-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203270-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203270-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203270-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203270-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

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
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-1367-2	2024-01-30	C162847	48780-1	1030e365-5400-111a-e063-dadaa90a10e2	5048b657-38e4-22f7-e054-00144ff8d46c
67296-1367-3	2024-01-30	C162847	48780-1	1030e365-5400-111a-e063-dadaa90a10e2	5048b657-38e4-22f7-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1367-2	Omeprazole	20 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	20		4
67296-1367-3	Omeprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1367	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REDPHARM DRUG, INC.]	4	Legacy NDC, 2 package rows	20220122_5048b657-38e4-22f7-e054-00144ff8d46c.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	QPharma Inc	50115204-74f7-17c1-e063-6394a90ab665	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Preferred Phharmaceuticals Inc.	319d990e-161b-4c16-b026-f55c413c7e8f	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Proficient Rx LP	61eab342-61fd-471f-8f70-95f9cbca0097	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	c1276463-7357-45b5-9f7e-8d3c4a550ff4	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	df1a4294-3893-4a11-b4d5-f3536678087e	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	af707c0a-5193-3f83-e053-2995a90a78ef	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Northwind Health Company, LLC	10a3fbc9-00c6-ad83-e063-6294a90ae1ad	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Northwind Health Company, LLC	f3038133-8bb2-044e-e053-2995a90a6e7d	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	QPharma, Inc.	f5dd5d63-1376-1ff7-e053-2a95a90a1d94	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	40b4e1b6-f64d-44d5-bfc2-0cb8f78d9e67	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	064b1418-0f42-4b18-9dee-cda40c5e1fca	2024-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	c311c1b9-8ec2-4ac0-baa2-a5063fba2d80	2024-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Rising Pharma Holdings, Inc.	a1b1c61b-d4fe-433d-ad31-0b11758976fa	2024-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	fe7d3352-d53f-4046-92ed-1eb5c917fbee	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	8d925ca6-83f1-4263-8218-4bf7cc8ceb39	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	9378c870-f2cc-4a60-b0fd-08a4d43857bc	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270
Omeprazole	OMEPRAZOLE	Aurobindo Pharma Limited	934601b6-fbba-43c4-a8ef-7a7dfe9f9a51	2024-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203270 application number: ANDA203270

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	5048b657-38e4-22f7-e054-00144ff8d46c	4
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	5048b657-38e4-22f7-e054-00144ff8d46c	4
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	5048b657-38e4-22f7-e054-00144ff8d46c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1367-3	67296136703	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67296-1367-3)	2015-08-19	0000-00-00	No	No	Current