Nisoldipine

Product NDC: 0378-2097
11-digit product format: 003782097
Labeler code: 0378
Product ID: 0378-2097_18276df2-9ea6-4560-b8fc-18b0d8025342
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nisoldipine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA091001
Marketing category: ANDA
Marketing start: 2011-01-28
Marketing end: 0000-00-00
Substance: NISOLDIPINE
Active strength: 17 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	0378-2097		D	Discontinued by firm		2026-10-15
excluded package	package	0378-2097	0378-2097-01	D	Discontinued by firm		2026-10-15

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

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	Approval date
A091001-001	NISOLDIPINE	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE / ORAL	2011-01-26
A091001-002	NISOLDIPINE	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE / ORAL	2011-01-26
A091001-003	NISOLDIPINE	NISOLDIPINE	25.5MG	TABLET, EXTENDED RELEASE / ORAL	2011-01-26
A091001-004	NISOLDIPINE	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE / ORAL	2011-01-26

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 · 176 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
2026-10-15 13:18:30	2026-09	A091001-001	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091001-002	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091001-003	NISOLDIPINE	25.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091001-004	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091001-001	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091001-002	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091001-003	NISOLDIPINE	25.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091001-004	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091001-001	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091001-002	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091001-003	NISOLDIPINE	25.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091001-004	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091001-001	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091001-002	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091001-003	NISOLDIPINE	25.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091001-004	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091001-001	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091001-002	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091001-003	NISOLDIPINE	25.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091001-004	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091001-001	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091001-002	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091001-003	NISOLDIPINE	25.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091001-004	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091001-001	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091001-002	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091001-003	NISOLDIPINE	25.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091001-004	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091001-001	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091001-002	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091001-003	NISOLDIPINE	25.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091001-004	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091001-001	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091001-002	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091001-003	NISOLDIPINE	25.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091001-004	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091001-001	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091001-002	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091001-003	NISOLDIPINE	25.5MG	TABLET, EXTENDED RELEASE / ORAL		2011-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091001-004	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-01-26	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A091001-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091001-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091001-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091001-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091001-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091001-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091001-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091001-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091001-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091001-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091001-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091001-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091001-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091001-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091001-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091001-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091001-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091001-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091001-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091001-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091001-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091001-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091001-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091001-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091001-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091001-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091001-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091001-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091001-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091001-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091001-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091001-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091001-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091001-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091001-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091001-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091001-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091001-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091001-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091001-002	AB	1	`ea99ee380514…`

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
0378-2097-01	EA - Each	0378-2097	0e339b9f-aabb-4f4d-bebf-6a90a791a440	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NISOLDIPINE	ACTIVE INGREDIENT	4I8HAB65SZ	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
NISOLDIPINE	ACTIVE MOIETY	4I8HAB65SZ	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-2097	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	10	Legacy NDC	20221115_00d506a4-74d6-4838-b008-3f9e7c017e08.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-2097-01	00378209701	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2097-01)	2011-01-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nisoldipine - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2022-09-30	HUMAN PRESCRIPTION DRUG LABEL	11