Omeprazole Magnesium

Product NDC: 53943-520
11-digit product format: 539430520
Labeler code: 53943
Product ID: 53943-520_c037b256-364d-d0fb-5d88-53d0f628d168
Type: HUMAN OTC DRUG
Nonproprietary name: Omeprazole Magnesium
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Discount Drug Mart, Inc
Application: ANDA078878
Marketing category: ANDA
Marketing start: 2016-11-18
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 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
A078878-001	OMEPRAZOLE MAGNESIUM	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL		RS	2009-06-05

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Omeprazole Magnesium
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
daeeba93-29d5-efb4-a591-3e72c4e50341	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
873ef493-6b37-49d8-ac7f-bfca4117d2c1	Product name	5	20210607
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53943-520-14	2021-12-01	daeeba93-29d5-efb4-a591-3e72c4e50341
53943-520-42	2021-12-01	daeeba93-29d5-efb4-a591-3e72c4e50341
53943-520-14	2021-01-29	daeeba93-29d5-efb4-a591-3e72c4e50341
53943-520-42	2021-01-29	daeeba93-29d5-efb4-a591-3e72c4e50341

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53943-520	OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DISCOUNT DRUG MART, INC]	3	Current NDC, Legacy NDC	20241112_daeeba93-29d5-efb4-a591-3e72c4e50341.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM	Gericare Pharmaceuticals	0e1f5d7c-5956-3be7-e054-00144ff8d46c	2025-07-28	Warnings	Exact identifier application applno (ANDA): 078878 application number: ANDA078878
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM	HEB	5d8b3f5f-f680-64ae-b360-c0bd06b2ac92	2025-07-23	Warnings	Exact identifier application applno (ANDA): 078878 application number: ANDA078878
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM	CVS Health Corp.	3bbfa87d-f8b7-19bd-9f12-39cba31ae0b3	2025-07-23	Warnings	Exact identifier application applno (ANDA): 078878 application number: ANDA078878
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM	Chain Drug Marketing Association	ab5d339b-2c02-611d-d5db-8e1891684fe0	2025-07-23	Warnings	Exact identifier application applno (ANDA): 078878 application number: ANDA078878
Acid Reducer	OMEPRAZOLE MAGNESIUM	LEADER/ Cardinal Health 110, Inc.	1dc00f13-d1f5-15a0-32cc-4fc041865e72	2025-07-23	Warnings	Exact identifier application applno (ANDA): 078878 application number: ANDA078878
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM	Albertsons Companies	302b1332-181b-834b-4154-d849cb3a1ef0	2025-07-23	Warnings	Exact identifier application applno (ANDA): 078878 application number: ANDA078878
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM	Discount Drug Mart, Inc	daeeba93-29d5-efb4-a591-3e72c4e50341	2025-07-23	Warnings	Exact identifier application applno (ANDA): 078878 application number: ANDA078878 ndc (product): 53943-520
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES	The Kroger Co.	8a6bbc31-7c50-a730-4233-e346fd7eb5ba	2025-07-22	Warnings	Exact identifier application applno (ANDA): 078878 application number: ANDA078878
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM	Dr. Reddy's Laboratories Inc.	fe0eb905-2042-aed1-a67d-a219e76f679b	2025-07-22	Warnings	Exact identifier application applno (ANDA): 078878 application number: ANDA078878
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM	Walgreens Company	ee8b1740-9bcf-5b70-bd8d-97f98303dc72	2025-07-22	Warnings	Exact identifier application applno (ANDA): 078878 application number: ANDA078878
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES	Wal-Mart Stores Inc	3160e212-9ee9-8316-f51e-4628862f654c	2025-07-22	Warnings	Exact identifier application applno (ANDA): 078878 application number: ANDA078878
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM	Chain Drug Consortium, LLC	39ac65c0-d957-125f-f00b-e3846a437489	2025-07-22	Warnings	Exact identifier application applno (ANDA): 078878 application number: ANDA078878
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM	Chain Drug Marketing Association	fdf1259b-e9d3-70a9-c209-e2eb6b152841	2025-07-22	Warnings	Exact identifier application applno (ANDA): 078878 application number: ANDA078878
Omeprazole Magnesium	OMEPRAZOLE MAGNESIUM	Dr. Reddy's Laboratories Limited	0e8fde83-a55c-edaf-3c66-e1fc77d0bc11	2025-05-28	Warnings	Exact identifier application applno (ANDA): 078878 application number: ANDA078878

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	daeeba93-29d5-efb4-a591-3e72c4e50341	4
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	daeeba93-29d5-efb4-a591-3e72c4e50341	4
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	daeeba93-29d5-efb4-a591-3e72c4e50341	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53943-520-14	53943052014	1 BOTTLE in 1 CARTON (53943-520-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	1 bottle	2016-11-18	0000-00-00	No	No	Current
53943-520-42	53943052042	3 BOTTLE in 1 CARTON (53943-520-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	3 bottle	2016-11-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole Magnesium - Discount Drug Mart, Inc	Discount Drug Mart, Inc	2025-07-23	HUMAN OTC DRUG LABEL	4