OMEPRAZOLE

Product NDC: 0363-4099
11-digit product format: 003634099
Labeler code: 0363
Product ID: 0363-4099_4565e652-447a-484b-b8d2-adde9454111c
Type: HUMAN OTC DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Walgreen Company
Application: ANDA216096
Marketing category: ANDA
Marketing start: 2026-03-06
Substance: OMEPRAZOLE MAGNESIUM
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216096-001	OMEPRAZOLE MAGNESIUM	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL			2022-05-24

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216096-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2022-05-24	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: OMEPRAZOLE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMEPRAZOLE MAGNESIUM	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
426QFE7XLK	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
97eaf0dc-380b-4039-aeb7-dde39942a9d6	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	Strength	SPL version
0363-4099-01	OMEPRAZOLE	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14		3
0363-4099-03	OMEPRAZOLE	3 in 1 CARTON	CAPSULE, DELAYED RELEASE	3		3

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GOOD SENSE OMEPRAZOLE	OMEPRAZOLE	L. Perrigo Company	b840439b-540b-465a-8faa-f7b1024c628e	2026-06-29	Warnings	Exact identifier application applno (ANDA): 216096 application number: ANDA216096
OMEPRAZOLE	OMEPRAZOLE	Safeway	b3ec4a44-5643-4438-b41b-e04946436719	2026-05-18	Warnings	Exact identifier application applno (ANDA): 216096 application number: ANDA216096
omeprazole	OMEPRAZOLE	Amazon.com Services LLC	7e0d319c-6917-45c4-b7e1-e870fc3fcea5	2026-05-13	Warnings	Exact identifier application applno (ANDA): 216096 application number: ANDA216096
OMEPRAZOLE	OMEPRAZOLE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	6479415a-ffb0-4d20-ad00-f091c8aaaadb	2026-03-31	Warnings	Exact identifier application applno (ANDA): 216096 application number: ANDA216096
OMEPRAZOLE	OMEPRAZOLE	Walgreen Company	97eaf0dc-380b-4039-aeb7-dde39942a9d6	2026-03-31	Warnings	Exact identifier application applno (ANDA): 216096 application number: ANDA216096 ndc (product): 0363-4099
omeprazole	OMEPRAZOLE	Meijer, Inc.	47c41c68-cb20-40f0-9d85-ea8db3328478	2026-03-06	Warnings	Exact identifier application applno (ANDA): 216096 application number: ANDA216096
omeprazole	OMEPRAZOLE MAGNESIUM	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	8edfcc08-a14e-4579-bd44-045267de5b79	2025-04-02	Warnings	Exact identifier application applno (ANDA): 216096 application number: ANDA216096
equate omeprazole	OMEPRAZOLE MAGNESIUM	WALMART INC.	6790b6c8-c258-4dfb-a400-25dc2812971f	2025-03-26	Warnings	Exact identifier application applno (ANDA): 216096 application number: ANDA216096
basic care omeprazole	OMEPRAZOLE MAGNESIUM	Amazon.com Services LLC	a4627be3-9845-428d-b3b1-c3096ae3d9b4	2024-09-05	Warnings	Exact identifier application applno (ANDA): 216096 application number: ANDA216096
omeprazole	OMEPRAZOLE MAGNESIUM	Safeway	7ae4d70f-08f1-4586-965f-5a32fbe21591	2024-06-04	Warnings	Exact identifier application applno (ANDA): 216096 application number: ANDA216096
omeprazole	OMEPRAZOLE MAGNESIUM	Walgreen Company	f56ff74d-116d-4a75-87dc-41c309f03918	2024-04-15	Warnings	Exact identifier application applno (ANDA): 216096 application number: ANDA216096
omeprazole	OMEPRAZOLE MAGNESIUM	Meijer, Inc.	0340ef94-d2b4-47af-a045-d0d031293984	2024-03-29	Warnings	Exact identifier application applno (ANDA): 216096 application number: ANDA216096

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
426QFE7XLK	OMEPRAZOLE MAGNESIUM	95382-33-5	OMEPRAZOLE MAGNESIUM
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	97eaf0dc-380b-4039-aeb7-dde39942a9d6	3
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	97eaf0dc-380b-4039-aeb7-dde39942a9d6	3
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	97eaf0dc-380b-4039-aeb7-dde39942a9d6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0363-4099-01	00363409901	14 in 1 BOTTLE					Historical
0363-4099-03	00363409903	3 BOTTLE in 1 CARTON (0363-4099-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0363-4099-01)	3 bottle	2026-03-06	No	No	Current