Omeprazole

Product NDC: 70518-3278
Requested package NDC: 70518-3278-1
11-digit product format: 705183278
Labeler code: 70518
Product ID: 70518-3278_4ee02091-1fc3-bab3-e063-6294a90acbfa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA212977
Marketing category: ANDA
Marketing start: 2021-11-29
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: 2027-12-31
Current FDA listing: Yes

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	70518-3278	70518-3278-1	D	Discontinued by firm		2026-07-31

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212977-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10
A212977-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10
A212977-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2024-12-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A212977-001	AB
A212977-002	AB
A212977-003	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	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A212977-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A212977-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A212977-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2024-12-27	`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	A212977-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A212977-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A212977-003	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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	REMEDYREPACK INC.	ded0df8b-1813-4595-ac2b-5499704bfd48	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212977 application number: ANDA212977 ndc (package): 70518-3278-1 ndc (product): 70518-3278 ndc11 (package): 70518327801
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	43090803-37de-77e3-e063-6294a90a8c43	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212977 application number: ANDA212977
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	6ea9a6f3-b756-4cdf-b3db-f666a2c17d66	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212977 application number: ANDA212977
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	530a8a66-48ad-474f-b170-c6fac95753ec	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212977 application number: ANDA212977
Omeprazole	OMEPRAZOLE	Golden State Medical Supply, Inc.	ded71262-d17f-3799-e053-2995a90a5427	2025-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212977 application number: ANDA212977
Omeprazole	OMEPRAZOLE	Golden State Medical Supply, Inc.	f873dc20-c817-5e4f-e053-6394a90a04f2	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212977 application number: ANDA212977
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	e87d2206-9c06-438c-947b-10b29a879d7b	2025-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212977 application number: ANDA212977
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	2e5d1b21-6b32-0c8d-e063-6294a90a8431	2025-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212977 application number: ANDA212977
Omeprazole	OMEPRAZOLE	NCS HealthCare of KY, LLC dba Vangard Labs	f226173f-4318-43e0-847a-8ea237e6b41d	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212977 application number: ANDA212977
Omeprazole	OMEPRAZOLE	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	1ab3d84c-c563-6f04-e063-6394a90a34ff	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212977 application number: ANDA212977
Omeprazole	OMEPRAZOLE	Proficient Rx LP	13b379ef-7982-434d-9e6b-e01cd2b398d2	2023-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212977 application number: ANDA212977
Omeprazole	OMEPRAZOLE	Proficient Rx LP	2fc5065c-5850-469b-b357-fa4df30a8f78	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212977 application number: ANDA212977
Omeprazole	OMEPRAZOLE	Xiromed, LLC	38bd8e13-591e-f11b-7d8a-11717c56493c	2022-02-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212977 application number: ANDA212977

Additional Listing Data#

Finished product: Yes
Brand name base: Omeprazole
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMEPRAZOLE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
KG60484QX9	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
ded0df8b-1813-4595-ac2b-5499704bfd48	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70518-3278-0	Omeprazole	30 in 1 BLISTER PACK	CAPSULE, DELAYED RELEASE	30	11
70518-3278-1	Omeprazole	30 in 1 BOTTLE, PLASTIC	CAPSULE, DELAYED RELEASE	30	11
70518-3278-2	Omeprazole	90 in 1 BOTTLE, PLASTIC	CAPSULE, DELAYED RELEASE	90	11
70518-3278-3	Omeprazole	30 in 1 BLISTER PACK	CAPSULE, DELAYED RELEASE	30	11
70518-3278-4	Omeprazole	60 in 1 BLISTER PACK	CAPSULE, DELAYED RELEASE	60	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3278	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REMEDYREPACK INC.]	9	Current NDC, Legacy NDC, 5 package rows	20241225_ded0df8b-1813-4595-ac2b-5499704bfd48.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	ded0df8b-1813-4595-ac2b-5499704bfd48	11
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	ded0df8b-1813-4595-ac2b-5499704bfd48	11
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	ded0df8b-1813-4595-ac2b-5499704bfd48	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3278-1	70518327801	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-3278-1)	2021-12-28	0000-00-00	No	No	Current