Application 078906

Type: ANDA
Sponsor: GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	240MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078906-001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078906-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A078906-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078906-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078906-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078906-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078906-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078906-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078906-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078906-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078906-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078906-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078906-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078906-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078906-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078906-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078906-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078906-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078906-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078906-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078906-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078906-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078906-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078906-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078906-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078906-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078906-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078906-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078906-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078906-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078906-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078906-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078906-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078906-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078906-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078906-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078906-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078906-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078906-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078906-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078906-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078906-001	AB	1	`cb3db0bc1861…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	REMEDYREPACK INC.	5dc5f087-c8da-4ed0-b532-ae44508958aa	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078906 application number: ANDA078906 ndc (product): 70518-1326
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	3c215e6c-d85a-4102-a1c2-f00fa3169a55	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078906 application number: ANDA078906 ndc (product): 55289-723
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	Northwind Health Company, LLC	62c3aadf-412e-41a5-9e57-2c48d962f90a	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078906 application number: ANDA078906 ndc (product): 51655-956
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	ba1bf1ae-9347-4d17-998b-14bf7b5984ce	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078906 application number: ANDA078906 ndc (product): 68462-260
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	af1249b0-e889-4f02-bdc2-54862de0545e	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078906 application number: ANDA078906 ndc (product): 68788-9790
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	3f14442c-8178-0bad-e054-00144ff8d46c	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078906 application number: ANDA078906 ndc (product): 66267-212
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	Proficient Rx LP	4ffa579e-1d85-4b3b-ae06-6a9334e0f9e1	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078906 application number: ANDA078906 ndc (product): 71205-017
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	c635f442-2349-4820-877a-a42e5f0a44b5	2019-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078906 application number: ANDA078906 ndc (product): 71610-268

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
10544-035	verapamil hydrochloride	verapamil hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
50090-1566	verapamil hydrochloride	verapamil hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1566	verapamil hydrochloride	verapamil hydrochloride	A-S Medication Solutions	ANDA	Current
50436-6914	verapamil hydrochloride	verapamil hydrochloride	Unit Dose Services	ANDA	Current
51655-956	Verapamil hydrochloride	Verapamil hydrochloride	Northwind Pharmaceuticals	ANDA	Current
53002-1129	verapamil hydrochloride	verapamil hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1129	verapamil hydrochloride	verapamil hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
55289-723	verapamil hydrochloride	verapamil hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-723	verapamil hydrochloride	verapamil hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-723	verapamil hydrochloride	verapamil hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-723	verapamil hydrochloride	verapamil hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
60687-515	Verapamil Hydrochloride	Verapamil Hydrochloride	American Health Packaging	ANDA	Current
60687-515	Verapamil Hydrochloride	Verapamil Hydrochloride	American Health Packaging	ANDA	Current
60687-515	Verapamil Hydrochloride	Verapamil Hydrochloride	American Health Packaging	ANDA	Current
66267-212	verapamil hydrochloride	verapamil hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-212	verapamil hydrochloride	verapamil hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-212	verapamil hydrochloride	verapamil hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68462-260	verapamil hydrochloride	verapamil hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-260	verapamil hydrochloride	verapamil hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-260	verapamil hydrochloride	verapamil hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-260	verapamil hydrochloride	verapamil hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68788-9790	Verapamil Hydrochloride	Verapamil Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9790	Verapamil Hydrochloride	Verapamil Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9790	Verapamil Hydrochloride	Verapamil Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9790	Verapamil Hydrochloride	Verapamil Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9790	Verapamil Hydrochloride	Verapamil Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-1326	verapamil hydrochloride	verapamil hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1326	verapamil hydrochloride	verapamil hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1326	verapamil hydrochloride	verapamil hydrochloride	REMEDYREPACK INC.	ANDA	Current
71205-017	verapamil hydrochloride	verapamil hydrochloride	Proficient Rx LP	ANDA	Current
71205-017	verapamil hydrochloride	verapamil hydrochloride	Proficient Rx LP	ANDA	Current
71335-0147	verapamil hydrochloride	verapamil hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0147	verapamil hydrochloride	verapamil hydrochloride	Bryant Ranch Prepack	ANDA	Current
71610-268	verapamil hydrochloride	verapamil hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current