Application 020943

Type: NDA
Sponsor: RECRO GAINESVILLE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VERELAN PM	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	100MG	Yes	No
002	VERELAN PM	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	200MG	Yes	No
003	VERELAN PM	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	300MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020943-001	VERELAN PM	VERAPAMIL HYDROCHLORIDE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25
N020943-002	VERELAN PM	VERAPAMIL HYDROCHLORIDE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25
N020943-003	VERELAN PM	VERAPAMIL HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	1998-11-25

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020943-001	VERELAN PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020943-002	VERELAN PM	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020943-003	VERELAN PM	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	1998-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020943-001	VERELAN PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020943-002	VERELAN PM	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020943-003	VERELAN PM	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	1998-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020943-001	VERELAN PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020943-002	VERELAN PM	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020943-003	VERELAN PM	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	1998-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020943-001	VERELAN PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020943-002	VERELAN PM	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020943-003	VERELAN PM	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	1998-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020943-001	VERELAN PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020943-002	VERELAN PM	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020943-003	VERELAN PM	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	1998-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020943-001	VERELAN PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020943-002	VERELAN PM	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020943-003	VERELAN PM	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	1998-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020943-001	VERELAN PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020943-002	VERELAN PM	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020943-003	VERELAN PM	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	1998-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020943-001	VERELAN PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020943-002	VERELAN PM	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020943-003	VERELAN PM	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	1998-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020943-001	VERELAN PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020943-002	VERELAN PM	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020943-003	VERELAN PM	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	1998-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020943-001	VERELAN PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020943-002	VERELAN PM	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020943-003	VERELAN PM	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	1998-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020943-001	VERELAN PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020943-002	VERELAN PM	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020943-003	VERELAN PM	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	1998-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020943-001	VERELAN PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020943-002	VERELAN PM	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020943-003	VERELAN PM	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	1998-11-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020943-001	VERELAN PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020943-002	VERELAN PM	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020943-003	VERELAN PM	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	1998-11-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020943-001	VERELAN PM	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1998-11-25	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020943-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020943-002	AB	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	N020943-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020943-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020943-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020943-002	AB	1	`ea99ee380514…`

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	Chartwell RX, LLC	18f6d349-8c5c-4443-ac65-16bf6619ecdc	2025-03-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020943 application number: NDA020943
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Wilshire Pharmaceuticals, Inc.	5f665d08-e1e4-422a-88c2-d8834abf9e1a	2024-11-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020943 application number: NDA020943

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62175-485	Verapamil Hydrochloride	Verapamil Hydrochloride	Lannett Company, Inc.	NDA	Current
62175-485	Verapamil Hydrochloride	Verapamil Hydrochloride	Lannett Company, Inc.	NDA	Current
62175-485	Verapamil Hydrochloride	Verapamil Hydrochloride	Lannett Company, Inc.	NDA	Current
62175-485	Verapamil Hydrochloride	Verapamil Hydrochloride	Lannett Company, Inc.	NDA	Current
62175-485	Verapamil Hydrochloride	Verapamil Hydrochloride	Kremers Urban Pharmaceuticals Inc.	NDA	Current
62175-486	Verapamil Hydrochloride	Verapamil Hydrochloride	Lannett Company, Inc.	NDA	Current
62175-486	Verapamil Hydrochloride	Verapamil Hydrochloride	Lannett Company, Inc.	NDA	Current
62175-486	Verapamil Hydrochloride	Verapamil Hydrochloride	Lannett Company, Inc.	NDA	Current
62175-486	Verapamil Hydrochloride	Verapamil Hydrochloride	Lannett Company, Inc.	NDA	Current
62175-486	Verapamil Hydrochloride	Verapamil Hydrochloride	Kremers Urban Pharmaceuticals Inc.	NDA	Current
62175-487	Verapamil Hydrochloride	Verapamil Hydrochloride	Lannett Company, Inc.	NDA	Current
62175-487	Verapamil Hydrochloride	Verapamil Hydrochloride	Lannett Company, Inc.	NDA	Current
62175-487	Verapamil Hydrochloride	Verapamil Hydrochloride	Lannett Company, Inc.	NDA	Current
62175-487	Verapamil Hydrochloride	Verapamil Hydrochloride	Lannett Company, Inc.	NDA	Current
62175-487	Verapamil Hydrochloride	Verapamil Hydrochloride	Kremers Urban Pharmaceuticals Inc.	NDA	Current
62175-570	VERELAN PM	verapamil hydrochloride	Lannett Company, Inc.	NDA	Current
62175-570	VERELAN PM	verapamil hydrochloride	Kremers Urban Pharmaceuticals Inc.	NDA	Current
62175-570	VERELAN PM	verapamil hydrochloride	Lannett Company, Inc.	NDA	Current
62175-570	VERELAN PM	verapamil hydrochloride	Lannett Company, Inc.	NDA	Current
62175-570	VERELAN PM	verapamil hydrochloride	Lannett Company, Inc.	NDA	Current
62175-571	VERELAN PM	verapamil hydrochloride	Lannett Company, Inc.	NDA	Current
62175-571	VERELAN PM	verapamil hydrochloride	Kremers Urban Pharmaceuticals Inc.	NDA	Current
62175-571	VERELAN PM	verapamil hydrochloride	Lannett Company, Inc.	NDA	Current
62175-571	VERELAN PM	verapamil hydrochloride	Lannett Company, Inc.	NDA	Current
62175-571	VERELAN PM	verapamil hydrochloride	Lannett Company, Inc.	NDA	Current
62175-572	VERELAN PM	verapamil hydrochloride	Lannett Company, Inc.	NDA	Current
62175-572	VERELAN PM	verapamil hydrochloride	Kremers Urban Pharmaceuticals Inc.	NDA	Current
62175-572	VERELAN PM	verapamil hydrochloride	Lannett Company, Inc.	NDA	Current
62175-572	VERELAN PM	verapamil hydrochloride	Lannett Company, Inc.	NDA	Current
62175-572	VERELAN PM	verapamil hydrochloride	Lannett Company, Inc.	NDA	Current
63629-7233	Verapamil Hydrochloride	Verapamil Hydrochloride	Bryant Ranch Prepack	NDA	Current
63629-7233	Verapamil Hydrochloride	Verapamil Hydrochloride	Bryant Ranch Prepack	NDA	Current
63629-8017	Verapamil Hydrochloride	Verapamil Hydrochloride	Bryant Ranch Prepack	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60230	SUPPL	2019-10-04
60225	SUPPL	2019-10-04
45916	SUPPL	2016-11-22
45938	SUPPL	2016-11-21
35690	SUPPL	2014-10-15
3817	SUPPL	2014-10-14
26264	SUPPL	2011-11-16
13792	SUPPL	2011-11-14
35688	SUPPL	2010-04-30
3815	SUPPL	2010-04-09
26263	SUPPL	2010-04-05
35689	SUPPL	2010-04-04
26262	SUPPL	2009-12-24
13791	SUPPL	2009-12-17
3816	SUPPL	2007-05-07
26261	SUPPL	2004-05-07
13790	SUPPL	2004-05-07
35687	ORIG	1998-11-25
26260	ORIG	1998-11-25
21294	ORIG	1998-11-25