Application 213232

Type: ANDA
Sponsor: CAPLIN

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
A213232-001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP		2020-03-25
A213232-002	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP		2020-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213232-001	AP
A213232-002	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 2 · 74 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	A213232-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213232-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213232-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213232-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213232-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213232-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213232-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213232-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213232-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213232-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213232-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213232-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213232-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213232-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213232-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213232-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213232-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213232-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213232-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213232-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213232-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213232-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213232-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213232-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213232-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213232-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213232-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213232-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213232-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213232-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213232-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213232-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213232-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213232-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213232-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213232-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213232-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213232-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213232-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213232-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-03-25	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A213232-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213232-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213232-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213232-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213232-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213232-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213232-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213232-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213232-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213232-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213232-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213232-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213232-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213232-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213232-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213232-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213232-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213232-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213232-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213232-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213232-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213232-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213232-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213232-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213232-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213232-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213232-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213232-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213232-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213232-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213232-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213232-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213232-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213232-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213232-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213232-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213232-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213232-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213232-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213232-002	AP	1	`87673890dc5c…`

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	REMEDYREPACK INC.	d7a749d0-4ab3-4fbb-8d7b-e09d68413c41	2025-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213232 application number: ANDA213232
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Caplin Steriles Limited	e18cc04c-a808-4d92-9b66-762cd787abc5	2025-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213232 application number: ANDA213232 ndc (product): 65145-114 ndc (product): 65145-113
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Baxter Healthcare Corporation	03c5daf8-5399-4d89-a747-9a9d7667b6e4	2020-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213232 application number: ANDA213232 ndc (product): 43066-035 ndc (product): 43066-031

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43066-031	Verapamil Hydrochloride	verapamil hydrochloride	Baxter Healthcare Corporation	ANDA	Current
43066-031	Verapamil Hydrochloride	verapamil hydrochloride	Baxter Healthcare Corporation	ANDA	Current
43066-031	Verapamil Hydrochloride	verapamil hydrochloride	Baxter Healthcare Corporation	ANDA	Current
43066-031	Verapamil Hydrochloride	verapamil hydrochloride	Baxter Healthcare Corporation	ANDA	Current
43066-035	Verapamil Hydrochloride	verapamil Hydrochloride	Baxter Healthcare Corporation	ANDA	Current
43066-035	Verapamil Hydrochloride	verapamil Hydrochloride	Baxter Healthcare Corporation	ANDA	Current
43066-035	Verapamil Hydrochloride	verapamil Hydrochloride	Baxter Healthcare Corporation	ANDA	Current
43066-035	Verapamil Hydrochloride	verapamil Hydrochloride	Baxter Healthcare Corporation	ANDA	Current
65145-113	Verapamil Hydrochloride	Verapamil Hydrochloride	Caplin Steriles Limited	ANDA	Current
65145-114	Verapamil Hydrochloride	Verapamil Hydrochloride	Caplin Steriles Limited	ANDA	Current