Omeprazole Magnesium

Product NDC: 59450-012
11-digit product format: 594500012
Labeler code: 59450
Product ID: 59450-012_272675b2-9db3-9e39-affe-6723b3ede96e
Type: HUMAN OTC DRUG
Nonproprietary name: Omeprazole Magnesium 20.6mg Capsules
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: The Kroger Co.
Application: ANDA078878
Marketing category: ANDA
Marketing start: 2016-01-01
Marketing end: 0000-00-00
Substance: OMEPRAZOLE MAGNESIUM
Active strength: 20 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	59450-012		D	Discontinued by firm	2026-08-07
excluded package	package	59450-012	59450-012-01	D	Discontinued by firm	2026-08-07
excluded package	package	59450-012	59450-012-27	D	Discontinued by firm	2026-08-07

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 · 20 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59450-012-27	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59450-012-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59450-012-27	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59450-012-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59450-012-27	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59450-012-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59450-012-27	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59450-012-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59450-012-27	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59450-012-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59450-012-27	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59450-012-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59450-012-27	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59450-012-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59450-012-27	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59450-012-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59450-012-27	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59450-012-01	`0efc9e666f02…`	`f202fb6c5f17…`

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
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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078878-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RS	2009-06-05	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OMEPRAZOLE MAGNESIUM	ACTIVE INGREDIENT	426QFE7XLK	OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]	2
omeprazole	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]	2
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]	2
CARRAGEENAN	INACTIVE INGREDIENT	5C69YCD2YJ	OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]	2
HYPROMELLOSE 2208 (3 MPA.S)	INACTIVE INGREDIENT	9H4L916OBU	OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]	2
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]	2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]	2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)	INACTIVE INGREDIENT	5KY68S2577	OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]	2
POTASSIUM CHLORIDE	INACTIVE INGREDIENT	660YQ98I10	OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]	2
RAW SUGAR	INACTIVE INGREDIENT	8M707QY5GH	OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59450-012	OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]	6	Legacy NDC	20241218_c962c55e-3699-511b-eb16-5da8b47fd0a2.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59450-012-01	59450001201	3 BOTTLE in 1 CARTON (59450-012-01) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	3 bottle	2016-01-01	0000-00-00	No	No	Current
59450-012-27	59450001227	2 BOTTLE in 1 CARTON (59450-012-27) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	2 bottle	2016-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole Magnesium 20.6mg Capsules - The Kroger Co.	The Kroger Co.	2024-12-16	HUMAN OTC DRUG LABEL	6