Nisoldipine

Product NDC: 0378-2222
11-digit product format: 003782222
Labeler code: 0378
Product ID: 0378-2222_f912a9d3-3306-477c-b868-a78c40f5809a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nisoldipine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA079051
Marketing category: ANDA
Marketing start: 2008-07-25
Marketing end: 2030-01-01
Substance: NISOLDIPINE
Active strength: 20 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: 0000-00-00
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	0378-2222		D	Discontinued by firm		2026-10-05
excluded package	package	0378-2222	0378-2222-01	D	Discontinued by firm		2026-10-05

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

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	Approval date
A079051-001	NISOLDIPINE	NISOLDIPINE	20MG	TABLET, EXTENDED RELEASE / ORAL	2008-07-25
A079051-002	NISOLDIPINE	NISOLDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	2008-07-25
A079051-003	NISOLDIPINE	NISOLDIPINE	40MG	TABLET, EXTENDED RELEASE / ORAL	2008-07-25

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A079051-001	NISOLDIPINE	20MG	TABLET, EXTENDED RELEASE / ORAL		2008-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079051-002	NISOLDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL		2008-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079051-003	NISOLDIPINE	40MG	TABLET, EXTENDED RELEASE / ORAL		2008-07-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079051-001	NISOLDIPINE	20MG	TABLET, EXTENDED RELEASE / ORAL		2008-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079051-002	NISOLDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL		2008-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079051-003	NISOLDIPINE	40MG	TABLET, EXTENDED RELEASE / ORAL		2008-07-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079051-001	NISOLDIPINE	20MG	TABLET, EXTENDED RELEASE / ORAL	RS	2008-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079051-002	NISOLDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL		2008-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079051-003	NISOLDIPINE	40MG	TABLET, EXTENDED RELEASE / ORAL	RS	2008-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079051-001	NISOLDIPINE	20MG	TABLET, EXTENDED RELEASE / ORAL	RS	2008-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079051-002	NISOLDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL		2008-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079051-003	NISOLDIPINE	40MG	TABLET, EXTENDED RELEASE / ORAL	RS	2008-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079051-001	NISOLDIPINE	20MG	TABLET, EXTENDED RELEASE / ORAL	RS	2008-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079051-002	NISOLDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL		2008-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079051-003	NISOLDIPINE	40MG	TABLET, EXTENDED RELEASE / ORAL	RS	2008-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079051-001	NISOLDIPINE	20MG	TABLET, EXTENDED RELEASE / ORAL	RS	2008-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079051-002	NISOLDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL		2008-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079051-003	NISOLDIPINE	40MG	TABLET, EXTENDED RELEASE / ORAL	RS	2008-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079051-001	NISOLDIPINE	20MG	TABLET, EXTENDED RELEASE / ORAL	RS	2008-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079051-002	NISOLDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL		2008-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079051-003	NISOLDIPINE	40MG	TABLET, EXTENDED RELEASE / ORAL	RS	2008-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079051-001	NISOLDIPINE	20MG	TABLET, EXTENDED RELEASE / ORAL	RS	2008-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079051-002	NISOLDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL		2008-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079051-003	NISOLDIPINE	40MG	TABLET, EXTENDED RELEASE / ORAL	RS	2008-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079051-001	NISOLDIPINE	20MG	TABLET, EXTENDED RELEASE / ORAL	RS	2008-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079051-002	NISOLDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL		2008-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079051-003	NISOLDIPINE	40MG	TABLET, EXTENDED RELEASE / ORAL	RS	2008-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079051-001	NISOLDIPINE	20MG	TABLET, EXTENDED RELEASE / ORAL	RS	2008-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079051-002	NISOLDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL		2008-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079051-003	NISOLDIPINE	40MG	TABLET, EXTENDED RELEASE / ORAL	RS	2008-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079051-001	NISOLDIPINE	20MG	TABLET, EXTENDED RELEASE / ORAL	RS	2008-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079051-002	NISOLDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL		2008-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079051-003	NISOLDIPINE	40MG	TABLET, EXTENDED RELEASE / ORAL	RS	2008-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079051-001	NISOLDIPINE	20MG	TABLET, EXTENDED RELEASE / ORAL	RS	2008-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079051-002	NISOLDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL		2008-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079051-003	NISOLDIPINE	40MG	TABLET, EXTENDED RELEASE / ORAL	RS	2008-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079051-001	NISOLDIPINE	20MG	TABLET, EXTENDED RELEASE / ORAL	RS	2008-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079051-002	NISOLDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL		2008-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079051-003	NISOLDIPINE	40MG	TABLET, EXTENDED RELEASE / ORAL	RS	2008-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079051-001	NISOLDIPINE	20MG	TABLET, EXTENDED RELEASE / ORAL	RS	2008-07-25	`301d65b070ca…`

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
0378-2222-01	EA - Each	0378-2222	90648095-4b80-4d3e-99e8-4f2029fd2f82	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.]	5
NISOLDIPINE	ACTIVE MOIETY	4I8HAB65SZ	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	5
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-2222	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	13	Legacy NDC	20230112_a6a8a8ba-3966-4f37-a58b-44d3b05bdc4e.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
0378-2222-01	00378222201	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2222-01)	2008-07-25	2030-01-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nisoldipine - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2017-06-28	HUMAN PRESCRIPTION DRUG LABEL	14