Application 019614

Type: NDA
Sponsor: RECRO GAINESVILLE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VERELAN	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	120MG	Yes	No
002	VERELAN	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	240MG	Yes	No
003	VERELAN	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	180MG	Yes	No
004	VERELAN	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	360MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019614-001	VERELAN	VERAPAMIL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1990-05-29
N019614-002	VERELAN	VERAPAMIL HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1990-05-29
N019614-003	VERELAN	VERAPAMIL HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-09
N019614-004	VERELAN	VERAPAMIL HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	1996-05-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N019614-001	AB
N019614-002	AB
N019614-003	AB

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 5 · 164 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	N019614-001	VERELAN	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1990-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019614-002	VERELAN	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1990-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019614-003	VERELAN	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019614-004	VERELAN	360MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	1996-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019614-001	VERELAN	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1990-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019614-002	VERELAN	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1990-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019614-003	VERELAN	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019614-004	VERELAN	360MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	1996-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019614-001	VERELAN	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1990-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019614-002	VERELAN	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1990-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019614-003	VERELAN	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019614-004	VERELAN	360MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	1996-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019614-001	VERELAN	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1990-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019614-002	VERELAN	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1990-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019614-003	VERELAN	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019614-004	VERELAN	360MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	1996-05-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019614-001	VERELAN	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1990-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019614-002	VERELAN	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1990-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019614-003	VERELAN	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019614-004	VERELAN	360MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	1996-05-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019614-001	VERELAN	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1990-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019614-002	VERELAN	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1990-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019614-003	VERELAN	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019614-004	VERELAN	360MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	1996-05-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019614-001	VERELAN	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1990-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019614-002	VERELAN	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1990-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019614-003	VERELAN	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019614-004	VERELAN	360MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	1996-05-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019614-001	VERELAN	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1990-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019614-002	VERELAN	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1990-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019614-003	VERELAN	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019614-004	VERELAN	360MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	1996-05-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019614-001	VERELAN	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1990-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019614-002	VERELAN	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1990-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019614-003	VERELAN	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019614-004	VERELAN	360MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	1996-05-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019614-001	VERELAN	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1990-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019614-002	VERELAN	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1990-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019614-003	VERELAN	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019614-004	VERELAN	360MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	1996-05-10	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	N019614-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019614-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019614-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019614-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019614-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019614-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019614-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019614-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019614-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019614-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019614-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019614-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019614-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019614-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019614-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019614-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019614-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019614-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019614-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019614-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019614-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019614-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019614-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019614-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019614-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019614-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019614-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019614-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019614-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019614-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019614-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019614-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019614-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019614-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019614-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019614-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019614-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019614-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019614-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019614-001	AB	1	`8072bd15b7f6…`

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	Bryant Ranch Prepack	522bafc3-4352-4840-b296-e399202c4162	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019614 application number: NDA019614 ndc (product): 63629-8842
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Teva Pharmaceuticals Inc	0742cf97-601b-4c13-a6c3-1a6a616ed292	2025-09-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019614 application number: NDA019614 ndc (product): 0591-2882 ndc (product): 0591-2886 ndc (product): 0591-2884 ndc (product): 0591-2880
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Wilshire Pharmaceuticals, Inc.	f9399858-fd7a-4b73-8759-3e5bf3af2666	2024-11-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019614 application number: NDA019614

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-2880	Verapamil Hydrochloride	verapamil hydrochloride	Teva Pharmaceuticals Inc	NDA	Current
0591-2880	Verapamil Hydrochloride	verapamil hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2880	Verapamil Hydrochloride	verapamil hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2880	Verapamil Hydrochloride	verapamil hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2882	Verapamil Hydrochloride	verapamil hydrochloride	Teva Pharmaceuticals Inc	NDA	Current
0591-2882	Verapamil Hydrochloride	verapamil hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2882	Verapamil Hydrochloride	verapamil hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2882	Verapamil Hydrochloride	verapamil hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2884	Verapamil Hydrochloride	verapamil hydrochloride	Teva Pharmaceuticals Inc	NDA	Current
0591-2884	Verapamil Hydrochloride	verapamil hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2884	Verapamil Hydrochloride	verapamil hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2884	Verapamil Hydrochloride	verapamil hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2886	Verapamil Hydrochloride	verapamil hydrochloride	Teva Pharmaceuticals Inc	NDA	Current
0591-2886	Verapamil Hydrochloride	verapamil hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2886	Verapamil Hydrochloride	verapamil hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-2886	Verapamil Hydrochloride	verapamil hydrochloride	Actavis Pharma, Inc.	NDA	Current
62175-580	VERELAN	verapamil hydrochloride	Lannett Company, Inc.	NDA	Current
62175-580	VERELAN	verapamil hydrochloride	Lannett Company, Inc.	NDA	Current
62175-580	VERELAN	verapamil hydrochloride	Lannett Company, Inc.	NDA	Current
62175-580	VERELAN	verapamil hydrochloride	Kremers Urban Pharmaceuticals Inc.	NDA	Current
62175-581	VERELAN	verapamil hydrochloride	Lannett Company, Inc.	NDA	Current
62175-581	VERELAN	verapamil hydrochloride	Lannett Company, Inc.	NDA	Current
62175-581	VERELAN	verapamil hydrochloride	Lannett Company, Inc.	NDA	Current
62175-581	VERELAN	verapamil hydrochloride	Kremers Urban Pharmaceuticals Inc.	NDA	Current
62175-582	VERELAN	verapamil hydrochloride	Lannett Company, Inc.	NDA	Current
62175-582	VERELAN	verapamil hydrochloride	Lannett Company, Inc.	NDA	Current
62175-582	VERELAN	verapamil hydrochloride	Lannett Company, Inc.	NDA	Current
62175-582	VERELAN	verapamil hydrochloride	Kremers Urban Pharmaceuticals Inc.	NDA	Current
62175-583	VERELAN	verapamil hydrochloride	Lannett Company, Inc.	NDA	Current
62175-583	VERELAN	verapamil hydrochloride	Lannett Company, Inc.	NDA	Current
62175-583	VERELAN	verapamil hydrochloride	Lannett Company, Inc.	NDA	Current
62175-583	VERELAN	verapamil hydrochloride	Kremers Urban Pharmaceuticals Inc.	NDA	Current
63629-4353	Verapamil Hydrochloride	verapamil hydrochloride	Bryant Ranch Prepack	NDA	Current
63629-8842	Verapamil Hydrochloride	verapamil hydrochloride	Bryant Ranch Prepack	NDA	Current
63629-8842	Verapamil Hydrochloride	verapamil hydrochloride	Bryant Ranch Prepack	NDA	Current
68151-0136	Verapamil Hydrochloride	verapamil hydrochloride	Carilion Materials Management	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60199	SUPPL	2019-10-02
60191	SUPPL	2019-10-02
45913	SUPPL	2016-11-22
45941	SUPPL	2016-11-21
11562	SUPPL	2014-10-15
1417	SUPPL	2014-10-10
17481	SUPPL	2011-11-16
11561	SUPPL	2011-11-14
1416	SUPPL	2010-04-09
33812	SUPPL	2010-04-04
17480	SUPPL	2010-04-02