Application 073568

Type: ANDA
Sponsor: IVAX SUB TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	240MG	No	No
002	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	120MG	No	No

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

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
A073568-001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL			1992-07-31
A073568-002	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL			1997-10-10

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 · 86 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
2026-09-14 22:38:34	2026-08	A073568-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL		1992-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A073568-002	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1997-10-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A073568-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL		1992-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A073568-002	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1997-10-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073568-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL		1992-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073568-002	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1997-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073568-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL		1992-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073568-002	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1997-10-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073568-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL		1992-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073568-002	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1997-10-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073568-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL		1992-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073568-002	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1997-10-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073568-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL		1992-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073568-002	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1997-10-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073568-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL		1992-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073568-002	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1997-10-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073568-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL		1992-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073568-002	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1997-10-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073568-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL		1992-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073568-002	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1997-10-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073568-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL		1992-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073568-002	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1997-10-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073568-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL		1992-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073568-002	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1997-10-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073568-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL		1992-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073568-002	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1997-10-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073568-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL		1992-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073568-002	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1997-10-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073568-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL		1992-07-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073568-002	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1997-10-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073568-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL		1992-07-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A073568-002	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1997-10-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073568-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	1992-07-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073568-002	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-10-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073568-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	1992-07-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A073568-002	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-10-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073568-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	1992-07-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A073568-002	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-10-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073568-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	1992-07-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A073568-002	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-10-10	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073568-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073568-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073568-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A073568-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073568-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A073568-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073568-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A073568-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073568-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A073568-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073568-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A073568-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073568-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073568-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073568-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A073568-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073568-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A073568-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073568-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A073568-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073568-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A073568-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073568-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A073568-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073568-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A073568-002	AB	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073568-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073568-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073568-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073568-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073568-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A073568-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073568-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A073568-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073568-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073568-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073568-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A073568-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073568-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A073568-002	AB	1	`e64feba35796…`

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 3 of 5 · 90 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fe0583bf-9986-e01e-e053-6294a90a0b26	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fe05b8d8-fdee-903b-e053-6394a90a2e05	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	febce7aa-7f5a-e0c1-e053-6394a90aebc4	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Caplin Steriles Limited	e18cc04c-a808-4d92-9b66-762cd787abc5	2025-01-16	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	d23c757d-39f8-48c3-ba63-df2cbe58c516	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	1076a3ef-de02-487f-8117-b4e80495db29	2024-12-26	Warnings, Adverse reactions	Name fallback brand name: Verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fdb7cd57-d33c-f5a3-e053-6294a90aff31	2024-12-13	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	a9a1a522-231b-41a1-95c6-0c75dbb62f47	2024-12-06	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	c87c7f7e-cdf5-42c7-a831-a7515d2d51d6	2024-12-06	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Wilshire Pharmaceuticals, Inc.	5f665d08-e1e4-422a-88c2-d8834abf9e1a	2024-11-27	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Wilshire Pharmaceuticals, Inc.	f9399858-fd7a-4b73-8759-3e5bf3af2666	2024-11-27	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	FRESENIUS KABI USA, LLC	38ca9270-5538-467a-a3e9-c27968f3aafe	2024-11-08	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Bryant Ranch Prepack	660a83a9-60be-42d5-bc70-fe384e93beaa	2024-10-24	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	A-S Medication Solutions	0b00ec93-0bb3-4181-a6ef-45206f0621f7	2024-10-16	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	3f14442c-8178-0bad-e054-00144ff8d46c	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: verapamil hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	a58f5f77-7e88-d622-e053-2a95a90a0d35	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Amneal Pharmaceuticals LLC	9055ed6b-f466-4f38-a9d9-f22e9ac97ad4	2024-07-10	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Bryant Ranch Prepack	f88dfe56-08bc-46b1-8f05-f886a16a89bc	2024-07-08	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7b321aa1-1b53-26d5-e053-2991aa0a1373	2024-06-12	Warnings, Adverse reactions	Name fallback brand name: VERAPAMIL HYDROCHLORIDE generic name: VERAPAMIL HYDROCHLORIDE
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Bryant Ranch Prepack	2f232216-db62-4dc6-a5a7-9139d7ac7589	2024-05-24	Warnings, Adverse reactions	Name fallback brand name: Verapamil Hydrochloride generic name: VERAPAMIL HYDROCHLORIDE

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-3589	Verapamil Hydrochloride	Verapamil Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
10544-541	Verapamil Hydrochloride	Verapamil Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
21695-868	Verapamil Hydrochloride	Verapamil Hydrochloride	Rebel Distributors Corp	ANDA	Current
53808-0329	Verapamil Hydrochloride	Verapamil Hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0953	Verapamil Hydrochloride	Verapamil Hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
63629-3052	Verapamil Hydrochloride	Verapamil Hydrochloride	Bryant Ranch Prepack	ANDA	Current