Omeprazole

Product NDC: 63548-7370
Requested package NDC: 63548-7370-8
11-digit product format: 635487370
Labeler code: 63548
Product ID: 63548-7370_74ebda17-011c-45bc-b22c-5182fc9f2ab8
Type: HUMAN OTC DRUG
Nonproprietary name: Omeprazole
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: PLD Acquisitions LLC DBA Av�ma Pharma Solutions
Application: ANDA206582
Marketing category: ANDA
Marketing start: 2024-10-31
Substance: OMEPRAZOLE MAGNESIUM
Active strength: 20.6 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
A206582-001	OMEPRAZOLE MAGNESIUM	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL			2020-06-01

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
2026-02-19 14:30 UTC	2026-02	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206582-001	OMEPRAZOLE MAGNESIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	2020-06-01	`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	20.6 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
71add294-ff24-4bbf-9067-7c56ed7c9f1a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
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
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
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
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63548-7370-2	Omeprazole	1 in 1 BOX	TABLET, DELAYED RELEASE	1	2
63548-7370-2	Omeprazole	42 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	42	2
63548-7370-4	Omeprazole	14 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	14	2
63548-7370-4	Omeprazole	1 in 1 BOX	TABLET, DELAYED RELEASE	1	2
63548-7370-8	Omeprazole	1 in 1 BOX	TABLET, DELAYED RELEASE	1	2
63548-7370-8	Omeprazole	28 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	28	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63548-7370	OMEPRAZOLE TABLET, DELAYED RELEASE [PLD ACQUISITIONS LLC DBA AV&EACUTE;MA PHARMA SOLUTIONS]	2	Current NDC, 6 package rows	20241222_71add294-ff24-4bbf-9067-7c56ed7c9f1a.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prilosec OTC	OMEPRAZOLE MAGNESIUM	The Procter & Gamble Manufacturing Company	37291cab-e350-d8e3-e063-6294a90a9cb1	2026-07-29	Warnings	Exact identifier application applno (ANDA): 206582 application number: ANDA206582
Omeprazole	OMEPRAZOLE	P & L Development, LLC	883e428a-e157-4bbf-8657-e7a93dc99e8c	2026-07-14	Warnings	Exact identifier application applno (ANDA): 206582 application number: ANDA206582
Omeprazole	OMEPRAZOLE	WALMART INC. (see also Equate)	d3c1ba08-680d-4e39-875c-1f1d42ae787c	2026-07-13	Warnings	Exact identifier application applno (ANDA): 206582 application number: ANDA206582
Omeprazole	OMEPRAZOLE	PLD Acquisitions LLC DBA Avma Pharma Solutions	d9c8a242-bdba-4f92-8629-692b47ebba21	2026-06-26	Warnings	Exact identifier application applno (ANDA): 206582 application number: ANDA206582
Omeprazole	OMEPRAZOLE	PLD Acquisitions LLC DBA Avma Pharma Solutions	71add294-ff24-4bbf-9067-7c56ed7c9f1a	2026-06-26	Warnings	Exact identifier application applno (ANDA): 206582 application number: ANDA206582 ndc (package): 63548-7370-8 ndc (product): 63548-7370 ndc11 (package): 63548737008
Omeprazole	OMEPRAZOLE	PLD Acquisitions LLC DBA Avma Pharma Solutions	e67bf2c6-0618-48e0-aa08-705501d86431	2026-06-26	Warnings	Exact identifier application applno (ANDA): 206582 application number: ANDA206582
Omeprazole	OMEPRAZOLE	PLD Acquisitions LLC DBA Avma Pharma Solutions	6a1aeb95-5760-4363-816a-fa8305979c50	2026-06-26	Warnings	Exact identifier application applno (ANDA): 206582 application number: ANDA206582
Omeprazole	OMEPRAZOLE	P & L Development, LLC	911a08c4-ba73-4600-a5f2-7f26ba8c8604	2026-06-25	Warnings	Exact identifier application applno (ANDA): 206582 application number: ANDA206582
Omeprazole	OMEPRAZOLE	Walgreens	b9683a94-fd44-4364-be0e-477ca1a29aba	2026-03-27	Warnings	Exact identifier application applno (ANDA): 206582 application number: ANDA206582
Omeprazole	OMEPRAZOLE	WinCo Foods, LLC	2782b98b-50e4-4a4e-8626-d34ebfd71bfb	2026-01-14	Warnings	Exact identifier application applno (ANDA): 206582 application number: ANDA206582
Omeprazole	OMEPRAZOLE	Family Dollar (FAMILY WELLNESS)	f2195d73-1fd5-4de2-aa5c-18741d11f4fc	2025-10-30	Warnings	Exact identifier application applno (ANDA): 206582 application number: ANDA206582
Prilosec OTC	OMEPRAZOLE MAGNESIUM	The Procter & Gamble Manufacturing Company	c7229a69-07e7-4690-8fc0-1f0f093bf230	2025-06-10	Warnings	Exact identifier application applno (ANDA): 206582 application number: ANDA206582
Omeprazole	OMEPRAZOLE	P & L Development, LLC	44a92926-1941-4fe8-9b2a-31a45289456f	2025-06-02	Warnings	Exact identifier application applno (ANDA): 206582 application number: ANDA206582

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	71add294-ff24-4bbf-9067-7c56ed7c9f1a	2
402014	omeprazole 20 MG Delayed Release Oral Tablet	SCD	71add294-ff24-4bbf-9067-7c56ed7c9f1a	2
402014	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Tablet	SY	71add294-ff24-4bbf-9067-7c56ed7c9f1a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
63548-7370-8	63548737008	1 BOTTLE, PLASTIC in 1 BOX (63548-7370-8) / 28 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC	2024-10-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OMEPRAZOLE MAGNESIUM DELAYED-RELEASE TABLETS	PLD Acquisitions LLC DBA Avéma Pharma Solutions	2026-06-26	HUMAN OTC DRUG LABEL	3