Omeprazole

Product NDC: 16714-123
11-digit product format: 167140123
Labeler code: 16714
Product ID: 16714-123_fe36a9a7-13d0-f4f1-1e31-b35cf651b79d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: NorthStar Rx LLC
Application: ANDA078490
Marketing category: ANDA
Marketing start: 2019-10-25
Substance: OMEPRAZOLE
Active strength: 40 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

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
A078490-001	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17
A078490-002	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16
A078490-003	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078490-001	AB
A078490-002	AB
A078490-003	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	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`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	A078490-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078490-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078490-003	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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	PD-Rx Pharmaceuticals, Inc.	0344268f-d8e6-48d5-b1e1-f750ed1d8a52	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	St. Mary's Medical Park Pharmacy	4c0cf466-f9e8-390e-e063-6294a90a2ed8	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	PD-Rx Pharmaceuticals, Inc.	96104ea6-c08f-40b5-83f5-d840b317f1fd	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	e07af8c9-559c-5a93-e053-2a95a90a2c63	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Dr. Reddy's Laboratories Limited	603d2d06-c5e8-4378-a422-8dca1a410af7	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	NorthStar Rx LLC	40a75dc7-49b7-5c9d-6c5f-d4682ec6922e	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490 ndc (product): 16714-123
Omeprazole	OMEPRAZOLE	REMEDYREPACK INC.	63b3982a-b541-4b0d-99d4-93a673e57d46	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Preferred Pharmaceuticals Inc.	288bdd5e-a0ac-4c5c-abe0-93183a28dcdd	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Northwind Health Company, LLC	4720cc17-013e-074e-e063-6294a90ac1f4	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Redpharm Drug	2fd1acb8-12dc-70b7-e063-6394a90a0399	2025-12-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	American Health Packaging	205652e1-7fbc-4b6a-bbd6-2fd346d812df	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals, Inc.	28515ff8-379d-5356-e063-6394a90af3f3	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	3724b8f7-52ff-a5f8-e063-6294a90acf20	2025-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Quallent Pharmaceuticals Health LLC	8090d4c3-3184-7812-53d7-aa30e14b79d1	2025-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	PHOENIX RX LLC	3b19d724-821b-61dc-e063-6294a90aa4d3	2025-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Advanced Rx of Tennessee, LLC	30955530-56d2-174d-e063-6294a90a413c	2025-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	40f66cac-bc23-43f9-9966-87cce458c996	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	2dcd48e4-9ffc-9cc2-e063-6294a90ae17e	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Coupler LLC	2cdc6809-3b1b-046a-e063-6394a90ae02a	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490
Omeprazole	OMEPRAZOLE	Preferred Pharmaceuticals Inc.	a806da8c-5f84-454d-966c-da1c48710f80	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078490 application number: ANDA078490

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMEPRAZOLE	40 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198051	Internal RxNorm lookup
199119	Internal RxNorm lookup
200329	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
40a75dc7-49b7-5c9d-6c5f-d4682ec6922e	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
16714-123-01	Omeprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	6
16714-123-02	Omeprazole	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	6
16714-123-03	Omeprazole	500 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	500	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-123-01	EA - Each	16714-123	1766dd81-b9c2-465a-b977-f6e197c87d01	1	2020-02-13
16714-123-02	EA - Each	16714-123	f0cb213d-4f0f-40ad-af1c-5389788bbc92	1	2020-02-13
16714-123-03	EA - Each	16714-123	0ebc12c4-2a88-4f16-8e82-c281a5c3d57f	1	2020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-123	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NORTHSTAR RX LLC]	5	Current NDC, Legacy NDC, 3 package rows	20231006_40a75dc7-49b7-5c9d-6c5f-d4682ec6922e.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
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	b4cd8ed1-d9d3-5b57-e053-2995a90a9f3c	7
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	b4cd8ed1-d9d3-5b57-e053-2995a90a9f3c	7
199119	omeprazole 10 MG Delayed Release Oral Capsule	PSN	40a75dc7-49b7-5c9d-6c5f-d4682ec6922e	6
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	40a75dc7-49b7-5c9d-6c5f-d4682ec6922e	6
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	40a75dc7-49b7-5c9d-6c5f-d4682ec6922e	6
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	40a75dc7-49b7-5c9d-6c5f-d4682ec6922e	6
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	40a75dc7-49b7-5c9d-6c5f-d4682ec6922e	6
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	40a75dc7-49b7-5c9d-6c5f-d4682ec6922e	6
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	40a75dc7-49b7-5c9d-6c5f-d4682ec6922e	6
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	40a75dc7-49b7-5c9d-6c5f-d4682ec6922e	6
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	8f13fd38-dc73-4072-bdc9-9474704a4121	3
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	8f13fd38-dc73-4072-bdc9-9474704a4121	3
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	e07af8c9-559c-5a93-e053-2a95a90a2c63	2
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	e07af8c9-559c-5a93-e053-2a95a90a2c63	2
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	a656a059-2b1a-44b3-85f8-af278032b54c	1
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	40f66cac-bc23-43f9-9966-87cce458c996	1
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	a656a059-2b1a-44b3-85f8-af278032b54c	1
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	40f66cac-bc23-43f9-9966-87cce458c996	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-123-01	16714012301	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-123-01)	2019-10-25	0000-00-00	No	No	Current
16714-123-02	16714012302	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-123-02)	2019-10-25	0000-00-00	No	No	Current
16714-123-03	16714012303	500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-123-03)	2019-10-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole	NuCare Pharmaceuticals,Inc. \| NuCare Pharmceuticals,Inc.	2026-03-11	HUMAN PRESCRIPTION DRUG LABEL	2
Omeprazole	NorthStar Rx LLC \| Dr. Reddy's Laboratories Limited- FTO3	2026-03-02	HUMAN PRESCRIPTION DRUG LABEL	6
Omeprazole	Aphena Pharma Solutions - Tennessee, LLC	2025-02-17	HUMAN PRESCRIPTION DRUG LABEL	1
Omeprazole DR Capsules	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	7
Omeprazole	A-S Medication Solutions	2024-01-04	HUMAN PRESCRIPTION DRUG LABEL	1
Omeprazole	A-S Medication Solutions	2023-11-22	HUMAN PRESCRIPTION DRUG LABEL	3