Application 210994

Type: ANDA
Sponsor: AMNEAL

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 44.

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
A210994-001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS			2018-07-13
A210994-002	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS			2018-07-13

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 · 88 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
2026-10-15 13:18:30	2026-09	A210994-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-07-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210994-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-07-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A210994-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210994-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-07-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210994-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210994-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-07-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210994-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210994-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210994-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210994-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210994-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210994-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210994-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210994-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210994-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210994-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210994-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210994-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210994-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210994-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210994-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210994-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210994-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210994-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210994-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210994-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210994-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210994-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210994-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210994-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210994-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210994-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210994-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210994-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210994-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210994-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210994-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210994-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210994-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210994-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-07-13	`4b0b4de00fa7…`

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
2026-02-19 14:30 UTC	2026-02	A210994-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210994-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210994-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210994-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210994-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210994-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210994-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210994-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210994-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210994-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210994-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210994-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210994-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210994-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210994-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210994-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210994-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210994-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210994-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210994-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210994-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210994-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210994-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210994-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210994-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210994-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210994-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210994-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210994-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210994-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210994-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210994-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210994-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210994-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210994-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210994-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210994-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210994-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210994-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210994-002	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Amneal Pharmaceuticals LLC	9055ed6b-f466-4f38-a9d9-f22e9ac97ad4	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210994 application number: ANDA210994 ndc (product): 70121-1585 ndc (product): 70121-1586

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
70121-1585	Verapamil Hydrochloride	Verapamil Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1585	Verapamil Hydrochloride	Verapamil Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1585	Verapamil Hydrochloride	Verapamil Hydrochloride	Amneal Biosciences LLC	ANDA	Current
70121-1585	Verapamil Hydrochloride	Verapamil Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1586	Verapamil Hydrochloride	Verapamil Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1586	Verapamil Hydrochloride	Verapamil Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1586	Verapamil Hydrochloride	Verapamil Hydrochloride	Amneal Biosciences LLC	ANDA	Current
70121-1586	Verapamil Hydrochloride	Verapamil Hydrochloride	Amneal Pharmaceuticals LLC	ANDA	Current