Omeprazole

Product NDC: 71610-876
Requested package NDC: 71610-876-80
11-digit product format: 716100876
Labeler code: 71610
Product ID: 71610-876_2dcd4083-bade-a7bd-e063-6294a90a7169
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA078490
Marketing category: ANDA
Marketing start: 2014-03-01
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: 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 · 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.

Product history page 1 of 4 · 123 observed 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
2026-02-19 14:30 UTC	2026-02	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078490-002	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078490-003	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-03-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078490-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-04-17	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078490-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078490-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078490-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078490-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078490-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078490-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078490-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078490-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078490-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078490-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078490-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078490-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078490-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078490-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078490-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078490-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078490-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078490-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078490-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078490-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078490-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078490-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078490-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078490-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Omeprazole
Listing expiration: 2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
2dcd48e4-9ffc-9cc2-e063-6294a90ae17e	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
71610-876-53	Omeprazole	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	60	1
71610-876-60	Omeprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	1
71610-876-70	Omeprazole	120 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	120	1
71610-876-80	Omeprazole	180 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	180	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-876-53	EA - Each	71610-876	ebf39e25-59e0-4760-a605-d9abc9ae0938	1	2025-05-14
71610-876-60	EA - Each	71610-876	a3860d08-82ca-4860-bf92-d317bff58f3c	1	2025-05-14
71610-876-70	EA - Each	71610-876	f3a4c25e-2801-45f7-9318-8f8affe72f22	1	2025-05-14
71610-876-80	EA - Each	71610-876	c84e8dba-720b-4ccf-8906-947edc5e69fc	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-876	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]	1	Current NDC, 4 package rows	20250213_2dcd48e4-9ffc-9cc2-e063-6294a90ae17e.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 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
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 ndc (package): 71610-876-80 ndc (product): 71610-876 ndc11 (package): 71610087680
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

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	2dcd48e4-9ffc-9cc2-e063-6294a90ae17e	1
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	2dcd48e4-9ffc-9cc2-e063-6294a90ae17e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71610-876-80	71610087680	180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-876-80)	2025-02-06	No	No	Current