SULAR

Product NDC: 59630-503
11-digit product format: 596300503
Labeler code: 59630
Product ID: 59630-503_afb5a339-f18f-4850-8041-24859b814174
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nisoldipine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Shionogi Inc.
Application: NDA020356
Marketing category: NDA
Marketing start: 1995-02-02
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	59630-503		D	Discontinued by firm		2026-10-15
excluded package	package	59630-503	59630-503-10	D	Discontinued by firm		2026-10-15

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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59630-503-10	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59630-503-10	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59630-503-10	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59630-503-10	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59630-503-10	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59630-503-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59630-503-10	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59630-503-10	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59630-503-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59630-503-10	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59630-503-10	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59630-503-10	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	59630-503-10	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 352 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
2026-10-15 13:18:30	2026-09	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	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	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	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	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	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	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	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020356-005	SULAR	34MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	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	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020356-007	SULAR	17MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020356-008	SULAR	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02	`c2088c7a36db…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 124 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020356-007	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020356-008	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020356-005	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020356-007	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020356-008	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020356-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020356-007	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020356-008	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020356-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020356-007	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020356-008	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020356-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020356-007	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020356-008	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020356-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020356-007	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020356-008	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020356-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020356-007	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020356-008	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020356-005	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020356-007	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020356-008	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020356-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020356-007	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020356-008	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020356-005	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020356-007	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020356-008	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020356-005	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020356-007	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020356-008	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020356-005	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020356-007	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020356-008	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020356-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020356-007	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020356-008	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020356-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020356-007	AB	1	`b00525d2431f…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59630-503-10	EA - Each	59630-503	ace3c991-e1b2-42a8-89ab-8edb29811b2d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NISOLDIPINE	ACTIVE INGREDIENT	4I8HAB65SZ	SULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	9
NISOLDIPINE	ACTIVE MOIETY	4I8HAB65SZ	SULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	9
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	SULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	9
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	SULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	9
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	9
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	SULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	9
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)	INACTIVE INGREDIENT	87Y6436BKR	SULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	9
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	9
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	SULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	9
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)	INACTIVE INGREDIENT	5KY68S2577	SULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	9
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	SULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	9
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	9
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	9
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	SULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	9

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SULAR ® (nisoldipine) Extended Release Tablets For Oral Use	Shionogi Inc. \| Aenova France SAS \| Bayer Pharma AG \| Catalent Germany Schorndorf GmbH	2015-03-19	HUMAN PRESCRIPTION DRUG LABEL	9