Application 212965

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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 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
A212965-001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212965-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION		RS	2020-07-06	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212965-001	VERAPAMIL HYDROCHLORIDE	2.5MG/ML	INJECTABLE / INJECTION	AP	RS	2020-07-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212965-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212965-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212965-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212965-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212965-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212965-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212965-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212965-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212965-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212965-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212965-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212965-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212965-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212965-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212965-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212965-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212965-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212965-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212965-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212965-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212965-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212965-001	AP	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212965-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212965-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212965-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212965-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212965-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212965-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212965-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212965-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212965-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212965-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212965-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212965-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212965-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212965-001	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	HF Acquisition Co LLC, DBA HealthFirst	df79ee3a-f0ed-1cc7-e053-2995a90af97f	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212965 application number: ANDA212965 ndc (product): 51662-1549
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Eugia US LLC	def3b9ba-523d-4b83-a80d-fa6f362e111c	2023-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212965 application number: ANDA212965 ndc (product): 55150-343 ndc (product): 55150-342
VERAPAMIL HCI	VERAPAMIL HCI	HF Acquisition Co LLC, DBA HealthFirst	df786377-7d2c-249b-e053-2a95a90aab22	2022-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212965 application number: ANDA212965 ndc (product): 51662-1548

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
51662-1548	VERAPAMIL HCI	VERAPAMIL HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1549	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
55150-342	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	AuroMedics Pharma LLC	ANDA	Current
55150-342	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	AuroMedics Pharma LLC	ANDA	Current
55150-342	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	AuroMedics Pharma LLC	ANDA	Current
55150-343	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	AuroMedics Pharma LLC	ANDA	Current
55150-343	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	AuroMedics Pharma LLC	ANDA	Current
55150-343	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	AuroMedics Pharma LLC	ANDA	Current