Nisoldipine

Product NDC: 0677-1981
11-digit product format: 006771981
Labeler code: 0677
Product ID: 0677-1981_64a32a66-e695-4fa9-b0e3-df33d91ffc4f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nisoldipine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: United Research Laboratories, Inc.
Application: NDA020356
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2009-09-01
Marketing end: 0000-00-00
Substance: NISOLDIPINE
Active strength: 34 mg/1
Pharmacologic classes: Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0677-1981		I	Inactivated by FDA		2026-10-05
excluded package	package	0677-1981	0677-1981-01	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0677-1981-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0677-1981-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0677-1981-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0677-1981-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0677-1981-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0677-1981-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0677-1981-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0677-1981-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0677-1981-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0677-1981-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0677-1981-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0677-1981-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0677-1981-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0677-1981-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0677-1981-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0677-1981-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0677-1981-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0677-1981-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0677-1981-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0677-1981-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0677-1981-01	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0677-1981-01	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020356-001	SULAR	NISOLDIPINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02
N020356-002	SULAR	NISOLDIPINE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02
N020356-003	SULAR	NISOLDIPINE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02
N020356-004	SULAR	NISOLDIPINE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02
N020356-005	SULAR	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02
N020356-006	SULAR	NISOLDIPINE	25.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02
N020356-007	SULAR	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02
N020356-008	SULAR	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020356-008	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 9 · 344 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
2026-09-14 22:38:34	2026-08	N020356-001	SULAR	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020356-002	SULAR	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020356-003	SULAR	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020356-004	SULAR	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020356-005	SULAR	34MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020356-006	SULAR	25.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020356-007	SULAR	17MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020356-008	SULAR	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020356-001	SULAR	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020356-002	SULAR	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020356-003	SULAR	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020356-004	SULAR	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020356-005	SULAR	34MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020356-006	SULAR	25.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020356-007	SULAR	17MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020356-008	SULAR	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020356-001	SULAR	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020356-002	SULAR	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020356-003	SULAR	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020356-004	SULAR	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020356-005	SULAR	34MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020356-006	SULAR	25.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020356-007	SULAR	17MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020356-008	SULAR	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020356-001	SULAR	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020356-002	SULAR	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020356-003	SULAR	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020356-004	SULAR	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020356-005	SULAR	34MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020356-006	SULAR	25.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020356-007	SULAR	17MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020356-008	SULAR	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020356-001	SULAR	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020356-002	SULAR	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020356-003	SULAR	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020356-004	SULAR	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020356-005	SULAR	34MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020356-006	SULAR	25.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020356-007	SULAR	17MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020356-008	SULAR	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02	`6a471c1ec25d…`

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
2026-09-14 22:38:34	2026-08	N020356-008	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020356-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020356-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020356-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020356-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020356-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020356-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020356-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020356-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020356-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020356-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020356-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020356-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020356-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020356-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020356-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020356-008	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020356-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020356-007	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020356-008	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020356-005	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020356-007	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020356-008	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020356-005	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020356-007	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020356-008	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020356-005	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020356-007	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020356-008	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020356-005	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020356-007	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020356-008	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020356-005	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020356-007	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020356-008	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020356-005	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020356-007	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020356-008	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020356-005	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020356-007	AB	1	`1e350fbaab3a…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e04fa8b-4f0f-e220-dece-f7d74308b047	Product name	2	20200505
63cce84a-c151-e237-b0c1-b5e9928f1ca7	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0677-1981-01	2019-10-21	C162847	48780-1	956f9ecf-db6c-621f-e053-dbdaa90a74ad	Nisoldipine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0677-1981-01	Nisoldipine	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100		2
0677-1981-01	Nisoldipine	1 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	1		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Nisoldipine	ACTIVE INGREDIENT	4I8HAB65SZ	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]	2
Nisoldipine	ACTIVE MOIETY	4I8HAB65SZ	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]	2
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]	2
FD&C yellow no. 5	INACTIVE INGREDIENT	I753WB2F1M	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]	2
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]	2
glyceryl behenate	INACTIVE INGREDIENT	R8WTH25YS2	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]	2
hypromellose	INACTIVE INGREDIENT	3NXW29V3WO	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]	2
lactose	INACTIVE INGREDIENT	J2B2A4N98G	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]	2
methacrylic acid - methyl methacrylate copolymer (1:1)	INACTIVE INGREDIENT	74G4R6TH13	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]	2
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]	2
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]	2
povidone	INACTIVE INGREDIENT	FZ989GH94E	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]	2
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]	2
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0677-1981	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]	2	Legacy NDC, 2 package rows	20090903_2abc5435-b2ca-4e08-89bc-ab7526781819.zip

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
Sular	NISOLDIPINE	Covis Pharma US, Inc	589157fa-d129-4de3-be3d-e0e1c22c5873	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020356 application number: NDA020356
Nisoldipine	NISOLDIPINE	Prasco Laboratories	8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb	2021-10-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020356 application number: NDA020356

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4I8HAB65SZ	NISOLDIPINE	63675-72-9	NISOLDIPINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
763519	nisoldipine 17 MG 24HR Extended Release Oral Tablet	PSN	2abc5435-b2ca-4e08-89bc-ab7526781819	2
763574	nisoldipine 25.5 MG 24HR Extended Release Oral Tablet	PSN	2abc5435-b2ca-4e08-89bc-ab7526781819	2
763589	nisoldipine 34 MG 24HR Extended Release Oral Tablet	PSN	2abc5435-b2ca-4e08-89bc-ab7526781819	2
790489	nisoldipine 8.5 MG 24HR Extended Release Oral Tablet	PSN	2abc5435-b2ca-4e08-89bc-ab7526781819	2
763519	24 HR nisoldipine 17 MG Extended Release Oral Tablet	SCD	2abc5435-b2ca-4e08-89bc-ab7526781819	2
763574	24 HR nisoldipine 25.5 MG Extended Release Oral Tablet	SCD	2abc5435-b2ca-4e08-89bc-ab7526781819	2
763589	24 HR nisoldipine 34 MG Extended Release Oral Tablet	SCD	2abc5435-b2ca-4e08-89bc-ab7526781819	2
790489	24 HR nisoldipine 8.5 MG Extended Release Oral Tablet	SCD	2abc5435-b2ca-4e08-89bc-ab7526781819	2
763519	nisoldipine 17 MG 24 HR Extended Release Oral Tablet	SY	2abc5435-b2ca-4e08-89bc-ab7526781819	2
763574	nisoldipine 25.5 MG 24 HR Extended Release Oral Tablet	SY	2abc5435-b2ca-4e08-89bc-ab7526781819	2
763589	nisoldipine 34 MG 24 HR Extended Release Oral Tablet	SY	2abc5435-b2ca-4e08-89bc-ab7526781819	2
790489	nisoldipine 8.5 MG 24 HR Extended Release Oral Tablet	SY	2abc5435-b2ca-4e08-89bc-ab7526781819	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
0677-1981-01	00677198101	100 in 1 BOTTLE	Historical