Omeprazole

Product NDC: 71610-963
Requested package NDC: 71610-963-80
11-digit product format: 716100963
Labeler code: 71610
Product ID: 71610-963_43091c83-9815-b7df-e063-6394a90aa05b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA212977
Marketing category: ANDA
Marketing start: 2019-02-20
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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.

Product history page 1 of 2 · 80 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
2026-08-18 06:07:40	2026-07	A212977-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212977-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212977-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2024-12-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212977-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212977-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212977-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2024-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212977-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212977-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212977-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2024-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212977-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212977-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212977-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2024-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212977-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212977-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212977-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2024-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212977-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212977-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212977-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2024-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212977-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212977-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212977-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2024-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212977-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212977-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212977-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212977-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212977-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212977-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212977-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212977-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212977-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212977-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212977-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212977-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212977-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212977-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212977-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212977-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212977-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212977-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212977-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-12-10	`5d02ea3f76ae…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212977-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212977-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212977-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212977-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212977-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212977-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212977-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212977-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212977-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212977-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212977-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212977-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212977-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212977-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212977-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212977-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212977-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212977-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212977-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212977-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212977-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212977-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212977-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212977-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212977-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212977-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212977-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212977-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212977-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212977-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212977-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212977-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212977-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212977-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212977-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212977-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212977-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212977-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212977-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212977-001	AB	1	`5d02ea3f76ae…`

Additional Listing Data#

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

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
43090803-37de-77e3-e063-6294a90a8c43	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
71610-963-60	Omeprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	1
71610-963-70	Omeprazole	120 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	120	1
71610-963-80	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
71610-963-60	EA - Each	71610-963	c590be1a-59b6-4798-891b-3d0b18a1bba1	1	2025-12-16
71610-963-70	EA - Each	71610-963	72b7a2c5-4d94-4895-bf51-048a77f4c6d0	1	2025-12-16
71610-963-80	EA - Each	71610-963	acf8683a-9a83-4952-8d66-8d41bc241370	1	2025-12-16

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 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	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212977 application number: ANDA212977
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	6ea9a6f3-b756-4cdf-b3db-f666a2c17d66	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212977 application number: ANDA212977
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 ndc (package): 71610-963-80 ndc (product): 71610-963 ndc11 (package): 71610096380
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

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	43090803-37de-77e3-e063-6294a90a8c43	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	43090803-37de-77e3-e063-6294a90a8c43	1
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	43090803-37de-77e3-e063-6294a90a8c43	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71610-963-80	71610096380	180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-963-80)	2025-11-07	No	No	Current