FDA.reportPublic FDA data

Nisoldipine

Product NDC
0677-1980
11-digit product format
006771980
Labeler code
0677
Product ID
0677-1980_64a32a66-e695-4fa9-b0e3-df33d91ffc4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nisoldipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
United Research Laboratories, Inc.
Application
NDA020356
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2009-09-01
Marketing end
0000-00-00
Substance
NISOLDIPINE
Active strength
26 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

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0677-1980-012019-10-21C16284748780-1956f9ecf-db6c-621f-e053-dbdaa90a74adNisoldipine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0677-1980-01Nisoldipine1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE12
0677-1980-01Nisoldipine100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NisoldipineACTIVE INGREDIENT4I8HAB65SZNISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]2
NisoldipineACTIVE MOIETY4I8HAB65SZNISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]2
carnauba waxINACTIVE INGREDIENTR12CBM0EIZNISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]2
FD&C yellow no. 5INACTIVE INGREDIENTI753WB2F1MNISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]2
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTNISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]2
glyceryl behenateINACTIVE INGREDIENTR8WTH25YS2NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]2
hypromelloseINACTIVE INGREDIENT3NXW29V3WONISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]2
lactoseINACTIVE INGREDIENTJ2B2A4N98GNISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]2
methacrylic acid - methyl methacrylate copolymer (1:1)INACTIVE INGREDIENT74G4R6TH13NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]2
polydextroseINACTIVE INGREDIENTVH2XOU12IENISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]2
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ANISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]2
povidoneINACTIVE INGREDIENTFZ989GH94ENISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]2
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JNISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPNISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0677-1980NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [UNITED RESEARCH LABORATORIES, INC.]2Legacy NDC, 2 package rows20090903_2abc5435-b2ca-4e08-89bc-ab7526781819.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
763519nisoldipine 17 MG 24HR Extended Release Oral TabletPSN2abc5435-b2ca-4e08-89bc-ab75267818192
763574nisoldipine 25.5 MG 24HR Extended Release Oral TabletPSN2abc5435-b2ca-4e08-89bc-ab75267818192
763589nisoldipine 34 MG 24HR Extended Release Oral TabletPSN2abc5435-b2ca-4e08-89bc-ab75267818192
790489nisoldipine 8.5 MG 24HR Extended Release Oral TabletPSN2abc5435-b2ca-4e08-89bc-ab75267818192
76351924 HR nisoldipine 17 MG Extended Release Oral TabletSCD2abc5435-b2ca-4e08-89bc-ab75267818192
76357424 HR nisoldipine 25.5 MG Extended Release Oral TabletSCD2abc5435-b2ca-4e08-89bc-ab75267818192
76358924 HR nisoldipine 34 MG Extended Release Oral TabletSCD2abc5435-b2ca-4e08-89bc-ab75267818192
79048924 HR nisoldipine 8.5 MG Extended Release Oral TabletSCD2abc5435-b2ca-4e08-89bc-ab75267818192
763519nisoldipine 17 MG 24 HR Extended Release Oral TabletSY2abc5435-b2ca-4e08-89bc-ab75267818192
763574nisoldipine 25.5 MG 24 HR Extended Release Oral TabletSY2abc5435-b2ca-4e08-89bc-ab75267818192
763589nisoldipine 34 MG 24 HR Extended Release Oral TabletSY2abc5435-b2ca-4e08-89bc-ab75267818192
790489nisoldipine 8.5 MG 24 HR Extended Release Oral TabletSY2abc5435-b2ca-4e08-89bc-ab75267818192

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0677-1980-01006771980011 in 1 CARTONHistorical