Application 214215

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	INJECTABLE;INJECTION	2.5MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A214215-001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP		2020-10-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214215-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214215-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	2020-10-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A214215-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214215-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214215-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214215-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214215-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214215-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214215-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214215-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214215-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214215-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214215-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214215-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214215-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214215-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214215-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214215-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214215-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214215-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214215-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214215-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214215-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214215-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214215-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A214215-001	AP	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214215-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214215-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214215-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214215-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214215-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214215-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214215-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214215-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214215-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214215-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214215-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214215-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214215-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214215-001	AP	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	a9a1a522-231b-41a1-95c6-0c75dbb62f47	2024-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214215 application number: ANDA214215
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	c87c7f7e-cdf5-42c7-a831-a7515d2d51d6	2024-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214215 application number: ANDA214215 ndc (product): 70710-1643 ndc (product): 70710-1644
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Zydus Lifesciences Limited	cccf4a5f-6c5d-4d52-97e4-fe7a2dbd28d8	2022-11-05		Exact identifier application applno (ANDA): 214215 application number: ANDA214215 ndc (product): 70771-1601 ndc (product): 70771-1602

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70710-1643	Verapamil Hydrochloride	Verapamil Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1643	Verapamil Hydrochloride	Verapamil Hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1644	Verapamil Hydrochloride	Verapamil Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1644	Verapamil Hydrochloride	Verapamil Hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70771-1601	Verapamil Hydrochloride	Verapamil Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1601	Verapamil Hydrochloride	Verapamil Hydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1602	Verapamil Hydrochloride	Verapamil Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1602	Verapamil Hydrochloride	Verapamil Hydrochloride	Zydus Lifesciences Limited	ANDA	Current