Nisoldipine

Product NDC: 66993-473
11-digit product format: 669930473
Labeler code: 66993
Product ID: 66993-473_a999e1d0-199c-4631-8a51-8dc27e05f3ab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nisoldipine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Prasco Laboratories
Application: NDA020356
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2012-02-27
Marketing end: 2027-05-31
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
Current FDA listing: Yes

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N020356-001	SULAR	NISOLDIPINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02
N020356-002	SULAR	NISOLDIPINE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02
N020356-003	SULAR	NISOLDIPINE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02
N020356-004	SULAR	NISOLDIPINE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02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N020356-006	SULAR	NISOLDIPINE	25.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02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.

Additional Listing Data#

Finished product: Yes
Brand name base: Nisoldipine

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NISOLDIPINE	17 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4I8HAB65SZ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
763519	Internal RxNorm lookup
763589	Internal RxNorm lookup
790489	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66993-473-02	Nisoldipine	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100		21
66993-473-02	Nisoldipine	1 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	1		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66993-473-02	EA - Each	66993-473	8de303cc-b26c-45cd-ab3f-3397e442ddb3	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 [PRASCO LABORATORIES]	8
NISOLDIPINE	ACTIVE MOIETY	4I8HAB65SZ	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]	8
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]	8
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]	8
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]	8
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)	INACTIVE INGREDIENT	87Y6436BKR	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]	8
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]	8
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]	8
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]	8
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]	8
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]	8
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66993-473	NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]	19	Current NDC, Legacy NDC, 2 package rows	20231221_8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb.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 ndc (product): 66993-473

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	8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb	21
763589	nisoldipine 34 MG 24HR Extended Release Oral Tablet	PSN	8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb	21
790489	nisoldipine 8.5 MG 24HR Extended Release Oral Tablet	PSN	8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb	21
763519	24 HR nisoldipine 17 MG Extended Release Oral Tablet	SCD	8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb	21
763589	24 HR nisoldipine 34 MG Extended Release Oral Tablet	SCD	8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb	21
790489	24 HR nisoldipine 8.5 MG Extended Release Oral Tablet	SCD	8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb	21
763519	nisoldipine 17 MG 24 HR Extended Release Oral Tablet	SY	8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb	21
763589	nisoldipine 34 MG 24 HR Extended Release Oral Tablet	SY	8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb	21
790489	nisoldipine 8.5 MG 24 HR Extended Release Oral Tablet	SY	8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66993-473-02	66993047302	1 BOTTLE in 1 CARTON (66993-473-02) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2012-02-27	2027-05-31	No	No	Current