Omeprazole

Product NDC: 0363-9980
11-digit product format: 003639980
Labeler code: 0363
Product ID: 0363-9980_8add376a-81a3-41e0-ba8d-037f7f56165a
Type: HUMAN OTC DRUG
Nonproprietary name: OMEPRAZOLE MAGNESIUM
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Walgreen Company
Application: ANDA210593
Marketing category: ANDA
Marketing start: 2021-01-05
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: 2026-12-31
Current FDA listing: Yes

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

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
A210593-001	OMEPRAZOLE MAGNESIUM	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL			2018-07-20

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210593-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	2018-07-20	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Omeprazole
Listing expiration: 2026-12-31

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
537b9a46-ecc8-4537-9657-c9ff7821dd4b	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
0363-9980-14	Omeprazole	1 in 1 CARTON	CAPSULE, DELAYED RELEASE	1	3
0363-9980-14	Omeprazole	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	3
0363-9980-28	Omeprazole	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	3
0363-9980-28	Omeprazole	2 in 1 CARTON	CAPSULE, DELAYED RELEASE	2	3
0363-9980-42	Omeprazole	3 in 1 CARTON	CAPSULE, DELAYED RELEASE	3	3
0363-9980-42	Omeprazole	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-9980	OMEPRAZOLE (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [WALGREEN COMPANY]	3	Current NDC, Legacy NDC, 6 package rows	20211207_537b9a46-ecc8-4537-9657-c9ff7821dd4b.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
omeprazole	OMEPRAZOLE	Rite Aid	b1ba65d1-8f68-4bae-bb9d-776bba348346	2022-03-03	Warnings	Exact identifier application applno (ANDA): 210593 application number: ANDA210593
Omeprazole	OMEPRAZOLE MAGNESIUM	Walgreen Company	537b9a46-ecc8-4537-9657-c9ff7821dd4b	2021-12-03	Warnings	Exact identifier application applno (ANDA): 210593 application number: ANDA210593 ndc (product): 0363-9980
Omeprazole	OMEPRAZOLE	CVS Pharamacy, Inc	0769e47f-f8f1-4b1c-a8cc-7c8385c74070	2021-04-16	Warnings	Exact identifier application applno (ANDA): 210593 application number: ANDA210593
OMEPRAZOLE	OMEPRAZOLE	AMERISOURCE BERGEN	47dce86f-d184-44cf-8ee3-18dad7f401b8	2021-03-31	Warnings	Exact identifier application applno (ANDA): 210593 application number: ANDA210593
Omeprazole	OMEPRAZOLE MAGNESIUM	UP & UP	ac10cf46-1dcc-483a-83d6-2fcb9896cc19	2020-12-04	Warnings	Exact identifier application applno (ANDA): 210593 application number: ANDA210593
Omeprazole	OMEPRAZOLE	Meijer Distribution Inc.	8f5f9bbb-48d2-4fb1-81a2-3cbf070ed573	2020-12-03	Warnings	Exact identifier application applno (ANDA): 210593 application number: ANDA210593
omeprazole	OMEPRAZOLE	INNOVUS PHARMACEUTICALS, INC.	ce5c9fdc-0c50-4315-8f11-e00c9810abd0	2020-08-06	Warnings	Exact identifier application applno (ANDA): 210593 application number: ANDA210593

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
426QFE7XLK	OMEPRAZOLE MAGNESIUM	95382-33-5	OMEPRAZOLE MAGNESIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	537b9a46-ecc8-4537-9657-c9ff7821dd4b	3
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	537b9a46-ecc8-4537-9657-c9ff7821dd4b	3
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	537b9a46-ecc8-4537-9657-c9ff7821dd4b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-9980-14	00363998014	1 BOTTLE in 1 CARTON (0363-9980-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	1 bottle	2021-01-05	0000-00-00	No	No	Current
0363-9980-28	00363998028	2 BOTTLE in 1 CARTON (0363-9980-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	2 bottle	2021-01-05	0000-00-00	No	No	Current
0363-9980-42	00363998042	3 BOTTLE in 1 CARTON (0363-9980-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	3 bottle	2021-01-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole	Walgreen Company \| Ohm Laboratories Inc. \| Srini Pharmaceuticals Private Limited	2021-12-03	HUMAN OTC DRUG LABEL	3