Acid Reducer

Product NDC: 55315-996
11-digit product format: 553150996
Labeler code: 55315
Product ID: 55315-996_5df31fd8-49c4-4a00-aadc-3f02860ab01f
Type: HUMAN OTC DRUG
Nonproprietary name: Omeprazole
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Fred's, Inc.
Application: ANDA206877
Marketing category: ANDA
Marketing start: 2018-06-06
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: 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
A206877-001	OMEPRAZOLE MAGNESIUM	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL			2018-06-06

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	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206877-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2018-06-06	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Acid Reducer
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
402014	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
7f00d0ed-4b7e-7011-e053-2a91aa0a2454	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
55315-996-04	Acid Reducer	3 in 1 CARTON	TABLET, DELAYED RELEASE	3	7
55315-996-04	Acid Reducer	14 in 1 BOTTLE	TABLET, DELAYED RELEASE	14	7
55315-996-74	Acid Reducer	14 in 1 BOTTLE	TABLET, DELAYED RELEASE	14	7
55315-996-74	Acid Reducer	1 in 1 CARTON	TABLET, DELAYED RELEASE	1	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55315-996	ACID REDUCER (OMEPRAZOLE) TABLET, DELAYED RELEASE [FRED'S, INC.]	7	Current NDC, Legacy NDC, 4 package rows	20240628_7f00d0ed-4b7e-7011-e053-2a91aa0a2454.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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acid Reducer	OMEPRAZOLE	INNOVUS PHARMACEUTICALS, INC.	a4e92bd2-8f75-4acc-9b75-df8332bd4cc4	2026-06-04	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877
Acid Reducer	OMEPRAZOLE	Rugby Laboratories	33990795-e994-4307-a570-9e8e8b44c473	2026-02-04	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877
Acid Reducer	OMEPRAZOLE	Fred's, Inc.	7f00d0ed-4b7e-7011-e053-2a91aa0a2454	2024-06-27	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877 ndc (product): 55315-996
Acid Reducer	OMEPRAZOLE	CVS Pharmacy, Inc.	3349ee88-e53b-4586-8d28-20ecf8fcb1a5	2024-06-27	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877
Acid Reducer	OMEPRAZOLE	Aurohealth LLC	3eb70031-6439-44cf-8056-3e2e1e4a7fa9	2024-06-27	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877
Acid Reducer	OMEPRAZOLE	Family Dollar Stores, LLC	6d8daf78-1672-4bbf-a022-514bf0a5ac9a	2024-06-17	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877
Acid Reducer	OMEPRAZOLE	NORTHEAST PHARMA	35ceccb5-dc3d-4ee1-bdac-35cb52c22f59	2024-06-15	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877
Acid Reducer	OMEPRAZOLE	Aurohealth LLC	287ceb12-e4d8-43c7-8cec-c4d23aa8fb12	2024-06-15	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877
Acid Reducer	OMEPRAZOLE	Cardinal Health	230e1aca-6644-4e6d-a6e1-9ba04cdcc8a8	2024-06-15	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877
Acid Reducer	OMEPRAZOLE	Bi-Mart	419659f9-098a-4a18-8bba-cd45157bfa50	2024-06-15	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877
Acid Reducer	OMEPRAZOLE	WALGREEN CO.	b9561780-e358-b610-e053-2a95a90af020	2024-06-15	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877
Acid Reducer	OMEPRAZOLE	KROGER COMPANY	eb5d02a8-4112-2066-e053-2a95a90abba3	2024-06-15	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877
Acid Reducer	OMEPRAZOLE	Aurohealth LLC	fde12bf8-3e3b-4813-a8c4-4385e7de8204	2024-06-14	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877
Acid Reducer	OMEPRAZOLE	Wal-Mart Stores, Inc.	1b4e75bf-0dcb-4fec-aca4-fc0132a79f5c	2024-06-14	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877
Acid Reducer	OMEPRAZOLE	Winco Foods, LLC.	0cb2949a-baf2-4276-a27b-8f3cc4b9a658	2024-06-14	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877
AMAZON BASIC CARE OMEPRAZOLE	OMEPRAZOLE	Amazon.com Services LLC	10efef7c-bdf4-36cf-e063-6394a90a8c0f	2024-05-10	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877
Acid Reducer	OMEPRAZOLE	DISCOUNT DRUG MART	ff2c8446-9d8b-4300-b157-884b48e98bb7	2023-12-02	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877
Acid Reducer	OMEPRAZOLE	Best Choice	43ea758b-6cea-44a2-b4d6-8f99211c8826	2023-12-02	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877
Acid Reducer	OMEPRAZOLE	RELIABLE 1 LABORATORIES LLC	f6b13640-6c71-4c3d-8eb5-c36fca201aee	2023-12-02	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877
Acid Reducer	OMEPRAZOLE	7-Eleven	61206416-e0c1-44d7-ad35-feb629361ba9	2023-12-02	Warnings	Exact identifier application applno (ANDA): 206877 application number: ANDA206877

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
402014	omeprazole 20 MG Delayed Release Oral Tablet	PSN	7f00d0ed-4b7e-7011-e053-2a91aa0a2454	7
402014	omeprazole 20 MG Delayed Release Oral Tablet	SCD	7f00d0ed-4b7e-7011-e053-2a91aa0a2454	7
402014	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet	SY	7f00d0ed-4b7e-7011-e053-2a91aa0a2454	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55315-996-04	55315099604	3 BOTTLE in 1 CARTON (55315-996-04) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE	3 bottle	2018-06-06	0000-00-00	No	No	Current
55315-996-74	55315099674	1 BOTTLE in 1 CARTON (55315-996-74) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE	1 bottle	2018-06-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acid Reducer - Fred's, Inc. \| Aurohealth LLC \| Aurobindo Pharma Limited	Fred's, Inc. \| Aurohealth LLC \| Aurobindo Pharma Limited	2024-06-27	Human OTC Drug Label	7