FDA.reportPublic FDA data

Felodipine

Product NDC
53489-368
11-digit product format
534890368
Labeler code
53489
Product ID
53489-368_6b871b9b-1cce-44db-a487-93cd6a6bb9cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felodipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
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
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53489-368-01EA - Each53489-368abf5eb61-53cc-4bc0-bb80-5a9cf91004d012012-07-24

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
FELODIPINEACTIVE INGREDIENTOL961R6O2CFELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FELODIPINEACTIVE MOIETYOL961R6O2CFELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZFELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PFELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOFELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AFELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EFELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFELODIPINE TABLET, FILM COATED FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1

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
402695felodipine 10 MG 24HR Extended Release Oral TabletPSN4bfc1982-6fe6-4d6d-99f2-f2d1cd7085401
402698felodipine 2.5 MG 24HR Extended Release Oral TabletPSN4bfc1982-6fe6-4d6d-99f2-f2d1cd7085401
402696felodipine 5 MG 24HR Extended Release Oral TabletPSN4bfc1982-6fe6-4d6d-99f2-f2d1cd7085401
40269524 HR felodipine 10 MG Extended Release Oral TabletSCD4bfc1982-6fe6-4d6d-99f2-f2d1cd7085401
40269824 HR felodipine 2.5 MG Extended Release Oral TabletSCD4bfc1982-6fe6-4d6d-99f2-f2d1cd7085401
40269624 HR felodipine 5 MG Extended Release Oral TabletSCD4bfc1982-6fe6-4d6d-99f2-f2d1cd7085401
402695felodipine 10 MG 24 HR Extended Release Oral TabletSY4bfc1982-6fe6-4d6d-99f2-f2d1cd7085401
402698felodipine 2.5 MG 24 HR Extended Release Oral TabletSY4bfc1982-6fe6-4d6d-99f2-f2d1cd7085401
402696felodipine 5 MG 24 HR Extended Release Oral TabletSY4bfc1982-6fe6-4d6d-99f2-f2d1cd7085401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53489-368-0153489036801100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-368-01) 2004-11-020000-00-00NoNoCurrent
53489-368-0353489036803250 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-368-03) 2004-11-020000-00-00NoNoCurrent
53489-368-0553489036805500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-368-05) 2004-11-020000-00-00NoNoCurrent
53489-368-075348903680730 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-368-07) 2004-11-020000-00-00NoNoCurrent
53489-368-10534890368101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-368-10) 2004-11-020000-00-00NoNoCurrent
53489-368-905348903689090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-368-90) 2004-11-020000-00-00NoNoCurrent