Application 211015

Type: ANDA
Sponsor: SOMERSET THERAPS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	SOLUTION;INTRAVENOUS	5MG/2ML (2.5MG/ML)	No	No
002	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	SOLUTION;INTRAVENOUS	10MG/4ML (2.5MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211015-001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP		2018-06-18
A211015-002	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP		2018-06-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A211015-001	AP
A211015-002	AP

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 3 · 82 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	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A211015-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211015-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211015-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211015-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211015-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211015-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211015-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211015-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211015-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211015-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211015-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211015-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211015-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211015-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211015-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211015-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211015-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211015-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211015-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211015-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211015-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211015-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211015-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211015-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211015-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211015-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211015-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211015-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211015-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211015-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211015-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211015-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211015-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211015-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211015-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211015-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211015-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211015-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211015-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211015-002	AP	1	`782e0a99824c…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Somerset Therapeutics, LLC	50131bbc-ad43-4708-946f-e4000828137c	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211015 application number: ANDA211015 ndc (product): 70069-272 ndc (product): 70069-271
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Henry Schein, Inc.	4f6ae43f-c28a-4eac-9b19-8b5d0c12dfaa	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211015 application number: ANDA211015 ndc (product): 0404-9966
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	4dcc46d8-76b0-fbd4-e063-6294a90ad9e6	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211015 application number: ANDA211015
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	4dcb137e-b01a-eb3a-e063-6294a90aaecc	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211015 application number: ANDA211015
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Henry Schein, Inc.	262608c5-843a-4122-b858-5affdc670389	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211015 application number: ANDA211015 ndc (product): 0404-9967
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Medical Purchasing Solutions, LLC	bfc7fa37-1ee3-5eb2-e053-2995a90a5622	2023-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211015 application number: ANDA211015 ndc (product): 71872-7243
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Medical Purchasing Solutions, LLC	e99a1aea-cd0a-59cb-e053-2a95a90a1147	2023-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211015 application number: ANDA211015 ndc (product): 71872-7291

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9966	Verapamil Hydrochloride	Verapamil Hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9966	Verapamil Hydrochloride	Verapamil Hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9967	VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9967	VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	Henry Schein, Inc.	ANDA	Current
52584-271	Verapamil Hydrochloride	Verapamil Hydrochloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-271	Verapamil Hydrochloride	Verapamil Hydrochloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-271	Verapamil Hydrochloride	Verapamil Hydrochloride	General Injectables and Vaccines, Inc.	ANDA	Current
52584-272	VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	General Injectables & Vaccines, Inc.	ANDA	Current
52584-272	VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	General Injectables & Vaccines, Inc.	ANDA	Current
52584-272	VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	General Injectables & Vaccines, Inc.	ANDA	Current
70069-271	Verapamil Hydrochloride	Verapamil Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-271	Verapamil Hydrochloride	Verapamil Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-271	Verapamil Hydrochloride	Verapamil Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-271	Verapamil Hydrochloride	Verapamil Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-271	Verapamil Hydrochloride	Verapamil Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-272	Verapamil Hydrochloride	Verapamil Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-272	Verapamil Hydrochloride	Verapamil Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-272	Verapamil Hydrochloride	Verapamil Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-272	Verapamil Hydrochloride	Verapamil Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-272	Verapamil Hydrochloride	Verapamil Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
71872-7243	Verapamil Hydrochloride	Verapamil Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7291	Verapamil Hydrochloride	Verapamil Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current