Omeprazole

Product NDC: 68071-2655
Requested package NDC: 68071-2655-1
11-digit product format: 680712655
Labeler code: 68071
Product ID: 68071-2655_da481c98-3cfe-1c05-e053-2995a90a8a35
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA075757
Marketing category: ANDA
Marketing start: 2019-07-01
Marketing end: 0000-00-00
Substance: OMEPRAZOLE
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68071-2655	68071-2655-1	I	Inactivated by FDA		2026-08-03

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075757-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28
A075757-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075757-001	AB
A075757-002	AB

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A075757-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075757-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2003-01-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A075757-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075757-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	St. Mary's Medical Park Pharmacy	db9f071b-85f4-061f-e053-2995a90a3ff5	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757
Omeprazole	OMEPRAZOLE	QPharma Inc	f6f6ad19-ff6a-7cd3-e053-6294a90ae1bf	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757
Omeprazole	OMEPRAZOLE	Northwind Health Company, LLC	f76c23d5-26b6-cfb2-e053-6294a90aea42	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757
Omeprazole	OMEPRAZOLE	Preferred Pharmaceuticals Inc.	0fb314cb-6291-422c-98ff-24d8449992f6	2025-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757
Omeprazole	OMEPRAZOLE	Chartwell RX, LLC	4b1a6f05-ae3e-4f29-bc2d-8e9f51e5fe3e	2025-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757
Omeprazole	OMEPRAZOLE	Sandoz Inc	516170d4-4913-4577-a2d2-f5c52d1e79c6	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757
Omeprazole	OMEPRAZOLE	Proficient Rx LP	ee0598a1-0e5e-40ff-ad88-b0adfc533ca0	2024-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	17664f71-154a-47c6-b83c-b349bbc8a98f	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757
Omeprazole	OMEPRAZOLE	Sandoz Inc	e4562da8-9d94-4417-9f80-c1ffd4247259	2023-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075757 application number: ANDA075757

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
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
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2655-1	2025-01-30	C162847	48780-1	2cef2736-a3ea-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
68071-2655-2	2025-01-30	C162847	48780-1	2cef2736-a3ea-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
68071-2655-3	2025-01-30	C162847	48780-1	2cef2736-a3ea-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
68071-2655-4	2025-01-30	C162847	48780-1	2cef2736-a3ea-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
68071-2655-6	2025-01-30	C162847	48780-1	2cef2736-a3ea-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
68071-2655-7	2025-01-30	C162847	48780-1	2cef2736-a3ea-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
68071-2655-8	2025-01-30	C162847	48780-1	2cef2736-a3ea-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
68071-2655-9	2025-01-30	C162847	48780-1	2cef2736-a3ea-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-2655-1	Omeprazole	15 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	15	2
68071-2655-2	Omeprazole	20 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	20	2
68071-2655-3	Omeprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	2
68071-2655-4	Omeprazole	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	2
68071-2655-6	Omeprazole	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	60	2
68071-2655-7	Omeprazole	7 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	7	2
68071-2655-8	Omeprazole	180 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	180	2
68071-2655-9	Omeprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2655	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.]	2	Legacy NDC, 8 package rows	20230418_da481f9e-dfa8-3682-e053-2a95a90a333c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
KG60484QX9	OMEPRAZOLE	73590-58-6	OMEPRAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	da481f9e-dfa8-3682-e053-2a95a90a333c	2
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	da481f9e-dfa8-3682-e053-2a95a90a333c	2
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	da481f9e-dfa8-3682-e053-2a95a90a333c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2655-1	68071265501	15 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2655-1)	2022-03-15	0000-00-00	No	No	Current