Application 075136

Type: ANDA
Sponsor: HOSPIRA

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	Yes

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
A075136-001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS			1998-10-20

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	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075136-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RS	1998-10-20	`cb3db0bc1861…`

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	A075136-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075136-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075136-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075136-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075136-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075136-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075136-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075136-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075136-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075136-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075136-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075136-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075136-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075136-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075136-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075136-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075136-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075136-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075136-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075136-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075136-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075136-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075136-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075136-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075136-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075136-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075136-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075136-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075136-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075136-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075136-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075136-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075136-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075136-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075136-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075136-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075136-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075136-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075136-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075136-001	AP	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Henry Schein, Inc.	9650680c-89ae-451b-aa75-4d34158866e7	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075136 application number: ANDA075136 ndc (product): 0404-9968
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	HF Acquisition Co. LLC, DBA HealthFirst	74d94dbf-0567-6c15-e053-2991aa0ac6e4	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075136 application number: ANDA075136 ndc (product): 51662-1270

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9968	Verapamil Hydrochloride	Verapamil Hydrochloride	Henry Schein, Inc.	ANDA	Current
0404-9968	Verapamil Hydrochloride	Verapamil Hydrochloride	Henry Schein, Inc.	ANDA	Current
0409-9633	Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-9633	Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-9633	Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-9633	Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
51662-1270	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	HF Acquisition Co. LLC, DBA HealthFirst	ANDA	Current
51662-1270	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	HF Acquisition Co. LLC, DBA HealthFirst	ANDA	Current
51662-1270	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	HF Acquisition Co. LLC, DBA HealthFirst	ANDA	Current
51662-1270	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	HF Acquisition Co. LLC, DBA HealthFirst	ANDA	Current
52584-633	Verapamil Hydrochloride	Verapamil Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-633	Verapamil Hydrochloride	Verapamil Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-633	Verapamil Hydrochloride	Verapamil Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-633	Verapamil Hydrochloride	Verapamil Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-633	Verapamil Hydrochloride	Verapamil Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42943	ORIG	1998-10-20
30770	ORIG	1998-10-20