Felodipine

Product NDC
68151-3083
11-digit product format
681513083
Labeler code
68151
Product ID
68151-3083_6f331df9-bf26-4f87-9a02-b1c996e456ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felodipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA075896
Marketing category
ANDA
Marketing start
2004-11-02
Marketing end
0000-00-00
Substance
FELODIPINE
Active strength
3 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6921cf71-4378-4166-972a-87039a02b9f2Product name520201015

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-3083-02020-01-31C16284748780-19d75b9d0-1fe7-f424-e053-dadaa90a57ceFELODIPINE EXTENDED-RELEASE TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-3083-0Felodipine1 in 1 PACKAGETABLET, FILM COATED, EXTENDED RE13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FelodipineACTIVE INGREDIENTOL961R6O2CFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FelodipineACTIVE MOIETYOL961R6O2CFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-3083FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160805_c4602657-d23d-43d9-8a4f-cdb390a010d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402698felodipine 2.5 MG 24HR Extended Release Oral TabletPSNc4602657-d23d-43d9-8a4f-cdb390a010d43
40269824 HR felodipine 2.5 MG Extended Release Oral TabletSCDc4602657-d23d-43d9-8a4f-cdb390a010d43
402698felodipine 2.5 MG 24 HR Extended Release Oral TabletSYc4602657-d23d-43d9-8a4f-cdb390a010d43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-3083-0681513083001 in 1 PACKAGEHistorical