Omeprazole

Product NDC: 50090-4829
Requested package NDC: 50090-4829-0
11-digit product format: 500904829
Labeler code: 50090
Product ID: 50090-4829_0720ca37-d87a-4387-be48-f21117a949e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA075576
Marketing category: ANDA
Marketing start: 2009-01-21
Marketing end: 0000-00-00
Substance: OMEPRAZOLE
Active strength: 20 mg/1
Pharmacologic classes: Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	50090-4829	50090-4829-0	I	Inactivated by FDA		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
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 3 · 90 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
2024-07-13 05:37 UTC	2024-07	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`301d65b070ca…`
2024-07-13 05:37 UTC	2024-07	A075576-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC	2024-07	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075576-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075576-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075576-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075576-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075576-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075576-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075576-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075576-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075576-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075576-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075576-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075576-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`3f01610625f2…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC	2024-07	A075576-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC	2024-07	A075576-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC	2024-07	A075576-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075576-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075576-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075576-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075576-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075576-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075576-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075576-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075576-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075576-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075576-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075576-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075576-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075576-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075576-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075576-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075576-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075576-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075576-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075576-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075576-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075576-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075576-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075576-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075576-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075576-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075576-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075576-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075576-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075576-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075576-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075576-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075576-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075576-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075576-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075576-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075576-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075576-001	AB	1	`3f01610625f2…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 14 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	OMEPRAZOLE	American Health Packaging	a17e415e-a559-4a8d-a455-699184a01523	2025-02-17	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
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

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4829-0	2023-01-30	C162847	48780-1	f386c649-9fb2-0266-e053-dadaa90a7c1a	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. OMEPRAZOLE delayed-release capsules, for oral use INITIAL U.S. APPROVAL: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4829-0	Omeprazole	32 in 1 BOTTLE, UNIT-DOSE	CAPSULE, DELAYED RELEASE	32		3
50090-4829-0	Omeprazole	1 in 1 BLISTER PACK	CAPSULE, DELAYED RELEASE	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4829	OMEPRAZOLE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]	3	Legacy NDC, 2 package rows	20210615_97f62c65-ef06-4cc6-8887-46c81266a80a.zip

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	97f62c65-ef06-4cc6-8887-46c81266a80a	3
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	97f62c65-ef06-4cc6-8887-46c81266a80a	3
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	97f62c65-ef06-4cc6-8887-46c81266a80a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4829-0	50090482900	32 BLISTER PACK in 1 BOTTLE, UNIT-DOSE (50090-4829-0) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK	32 blister pack	2020-01-08	0000-00-00	No	No	Current