Application 212977

Type: ANDA
Sponsor: XIROMED

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OMEPRAZOLE	OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	10MG	No	No
002	OMEPRAZOLE	OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	20MG	No	No
003	OMEPRAZOLE	OMEPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	40MG	No	No

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…`

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 ndc (product): 70518-3278
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 ndc (product): 50090-5901
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	530a8a66-48ad-474f-b170-c6fac95753ec	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212977 application number: ANDA212977 ndc (product): 50090-5902
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 ndc (product): 51407-641
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 ndc (product): 71610-663
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 ndc (product): 0615-8406
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 ndc (product): 71205-613
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 ndc (product): 71205-907
Omeprazole	OMEPRAZOLE	Xiromed, LLC	38bd8e13-591e-f11b-7d8a-11717c56493c	2022-02-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212977 application number: ANDA212977 ndc (product): 70700-150 ndc (product): 70700-149

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8406	Omeprazole	Omeprazole	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8406	Omeprazole	Omeprazole	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
50090-5901	Omeprazole	Omeprazole	A-S Medication Solutions	ANDA	Current
50090-5902	Omeprazole	Omeprazole	A-S Medication Solutions	ANDA	Current
50090-5903	Omeprazole	Omeprazole	A-S Medication Solutions	ANDA	Current
51407-641	Omeprazole	Omeprazole	Golden State Medical Supply, Inc.	ANDA	Current
51407-641	Omeprazole	Omeprazole	Golden State Medical Supply, Inc.	ANDA	Current
70518-3278	Omeprazole	Omeprazole	REMEDYREPACK INC.	ANDA	Current
70518-3278	Omeprazole	Omeprazole	REMEDYREPACK INC.	ANDA	Current
70518-3278	Omeprazole	Omeprazole	REMEDYREPACK INC.	ANDA	Current
70700-149	Omeprazole	Omeprazole	Xiromed, LLC	ANDA	Current
70700-149	Omeprazole	Omeprazole	Xiromed, LLC	ANDA	Current
70700-149	Omeprazole	Omeprazole	Xiromed, LLC	ANDA	Current
70700-149	Omeprazole	Omeprazole	Xiromed, LLC	ANDA	Current
70700-149	Omeprazole	Omeprazole	Xiromed, LLC	ANDA	Current
70700-149	Omeprazole	Omeprazole	Xiromed, LLC	ANDA	Current
70700-149	Omeprazole	Omeprazole	Xiromed, LLC	ANDA	Current
70700-149	Omeprazole	Omeprazole	Xiromed, LLC	ANDA	Current
70700-150	Omeprazole	Omeprazole	Xiromed, LLC	ANDA	Current
70700-150	Omeprazole	Omeprazole	Xiromed, LLC	ANDA	Current
70700-150	Omeprazole	Omeprazole	Xiromed, LLC	ANDA	Current
70700-150	Omeprazole	Omeprazole	Xiromed, LLC	ANDA	Current
70700-150	Omeprazole	Omeprazole	Xiromed, LLC	ANDA	Current
70700-150	Omeprazole	Omeprazole	Xiromed, LLC	ANDA	Current
70700-150	Omeprazole	Omeprazole	Xiromed, LLC	ANDA	Current
70700-150	Omeprazole	Omeprazole	Xiromed, LLC	ANDA	Current
71205-613	Omeprazole	Omeprazole	Proficient Rx LP	ANDA	Current
71205-613	Omeprazole	Omeprazole	Proficient Rx LP	ANDA	Current
71205-613	Omeprazole	Omeprazole	Proficient Rx LP	ANDA	Current
71205-907	Omeprazole	Omeprazole	Proficient Rx LP	ANDA	Current
71205-907	Omeprazole	Omeprazole	Proficient Rx LP	ANDA	Current
71610-663	Omeprazole	Omeprazole	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-663	Omeprazole	Omeprazole	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-663	Omeprazole	Omeprazole	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current