Omeprazole

Product NDC: 80425-0169
11-digit product format: 804250169
Labeler code: 80425
Product ID: 80425-0169_4cf007cf-ee50-ce69-e063-6394a90a971a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA091672
Marketing category: ANDA
Marketing start: 2014-10-31
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	RLD / RS	Approval date
A091672-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2014-10-31
A091672-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2014-10-31
A091672-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RS	2014-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091672-001	AB
A091672-002	AB
A091672-003	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	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091672-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091672-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091672-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2014-10-31	`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	A091672-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091672-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091672-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091672-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091672-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091672-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091672-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091672-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091672-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091672-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091672-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091672-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091672-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091672-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091672-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091672-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091672-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091672-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091672-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091672-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091672-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091672-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091672-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091672-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091672-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091672-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091672-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091672-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091672-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091672-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091672-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091672-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091672-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091672-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091672-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091672-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091672-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091672-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091672-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091672-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Omeprazole
Brand name suffix: DR
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 · 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
c8bf92c9-1bab-7985-e053-2995a90a0225	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
80425-0169-1	OmeprazoleDR	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	8
80425-0169-2	OmeprazoleDR	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	60	8
80425-0169-3	OmeprazoleDR	4 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	4	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0169-1	EA - Each	80425-0169	7da0197c-5994-4368-be4a-7e443b21c60c	1	2023-06-06
80425-0169-2	EA - Each	80425-0169	6e3f550b-1bde-4323-aeda-9aec77412339	1	2023-04-07
80425-0169-3	EA - Each	80425-0169	bb829510-36bc-4151-a0d4-04d3929be609	1	2026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0169	OMEPRAZOLE DR (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	7	Current NDC, Legacy NDC, 3 package rows	20250101_c8bf92c9-1bab-7985-e053-2995a90a0225.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	REMEDYREPACK INC.	a19ce586-59b7-4c2e-9e8d-12e8f0f058e2	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	HAWAII REPACK, INC.	9359e826-5263-44fc-8dd3-9d0852fe42d6	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	dcaadc8c-32d1-476f-b821-973c012b7fa7	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	Unit Dose Solutions, Inc.	557d4c2c-5541-3a51-e063-6394a90ad278	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	REMEDYREPACK INC.	d9b3918c-a66e-4277-8b8f-b7ece93fa7db	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	ST. MARY'S MEDICAL PARK PHARMACY	4f5c91e6-6377-ca94-e063-6294a90a2f99	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole DR	OMEPRAZOLE	Advanced Rx Pharmacy of Tennessee, LLC	c8bf92c9-1bab-7985-e053-2995a90a0225	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672 ndc (product): 80425-0169
Omeprazole	OMEPRAZOLE	Glenmark Pharmaceuticals Inc., USA	c6c22be1-659d-4e71-b292-701e27da201b	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	Preferred Pharmaceuticals Inc.	fa0395a7-4353-4d64-9de8-d15857a7031c	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	17ccdbe0-19c1-498d-8e81-578be549b4e5	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	Preferred Pharmaceuticals Inc.	aa8fc2ea-3942-453b-bc19-1e4b14ba6926	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	3d6e07d1-38b1-f2ab-e063-6294a90a34ac	2025-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	bab55f83-ba03-49a0-842a-19c9976b7fe8	2025-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	5bda70ae-c3f6-450b-892f-6814795dd6ca	2025-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	PHOENIX RX LLC	3a9baece-03be-6c77-e063-6394a90a7032	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	Asclemed USA, Inc.	9c41bcfa-b08b-3ac3-e053-2a95a90ae1c0	2025-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	NCS HealthCare of KY, LLC dba Vangard Labs	d1e0c8fc-1f15-45a4-a80f-653a1dae5e56	2025-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole DR	OMEPRAZOLE	Advanced Rx of Tennessee, LLC	af85afda-6b0c-d657-e053-2a95a90afb4b	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	30e58465-c5d2-4925-85bb-53faa6135c5c	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672
Omeprazole	OMEPRAZOLE	Proficient Rx LP	5ad413ed-a21b-4f8b-9322-8fbb813b14d3	2024-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091672 application number: ANDA091672

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	c8bf92c9-1bab-7985-e053-2995a90a0225	8
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	c8bf92c9-1bab-7985-e053-2995a90a0225	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
80425-0169-1	80425016901	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0169-1)	2014-10-31	0000-00-00	No	No	Current
80425-0169-2	80425016902	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0169-2)	2014-10-31		No	No	Current
80425-0169-3	80425016903	4 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0169-3)	2014-10-31		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole DR Capsules	Advanced Rx Pharmacy of Tennessee, LLC	2026-03-13	HUMAN PRESCRIPTION DRUG LABEL	8