FDA.reportPublic FDA data

Nisoldipine

Product NDC
66993-472
11-digit product format
669930472
Labeler code
66993
Product ID
66993-472_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
8.5 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

Additional Listing Data#

Finished product
Yes
Brand name base
Nisoldipine

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NISOLDIPINE8.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4I8HAB65SZ
Rxcui763519, 763589, 790489

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e04fa8b-4f0f-e220-dece-f7d74308b047Product name220200505
63cce84a-c151-e237-b0c1-b5e9928f1ca7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66993-472-02Nisoldipine1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE121
66993-472-02Nisoldipine100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-472-02EA - Each66993-47267646b06-9b0d-429b-8160-aaaee153d59a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NISOLDIPINEACTIVE INGREDIENT4I8HAB65SZNISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]8
NISOLDIPINEACTIVE MOIETY4I8HAB65SZNISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]8
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZNISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]8
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MNISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]8
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]8
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)INACTIVE INGREDIENT87Y6436BKRNISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]8
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GNISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]8
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]8
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IENISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]8
POVIDONESINACTIVE INGREDIENTFZ989GH94ENISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-472NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES]19Current NDC, Legacy NDC, 2 package rows20231221_8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
763519nisoldipine 17 MG 24HR Extended Release Oral TabletPSN8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb21
763589nisoldipine 34 MG 24HR Extended Release Oral TabletPSN8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb21
790489nisoldipine 8.5 MG 24HR Extended Release Oral TabletPSN8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb21
76351924 HR nisoldipine 17 MG Extended Release Oral TabletSCD8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb21
76358924 HR nisoldipine 34 MG Extended Release Oral TabletSCD8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb21
79048924 HR nisoldipine 8.5 MG Extended Release Oral TabletSCD8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb21
763519nisoldipine 17 MG 24 HR Extended Release Oral TabletSY8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb21
763589nisoldipine 34 MG 24 HR Extended Release Oral TabletSY8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb21
790489nisoldipine 8.5 MG 24 HR Extended Release Oral TabletSY8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66993-472-02669930472021 BOTTLE in 1 CARTON (66993-472-02) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE1 bottle2012-02-272027-05-31NoNoCurrent