FDA.reportPublic FDA data

Felodipine

Product NDC
68462-233
11-digit product format
684620233
Labeler code
68462
Product ID
68462-233_8663994d-841f-427a-93db-b4c9d10bad27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felodipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA090365
Marketing category
ANDA
Marketing start
2010-12-20
Substance
FELODIPINE
Active strength
2.5 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Felodipine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FELODIPINE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOL961R6O2C
Rxcui402695, 402696, 402698

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-233-01Felodipine100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1007
68462-233-10Felodipine1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10007
68462-233-11Felodipine10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE107
68462-233-11Felodipine10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE107
68462-233-90Felodipine90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-233-01EA - Each68462-233ad3c3be1-ce27-40ac-a2d4-f1b476b5f05912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FELODIPINEACTIVE INGREDIENTOL961R6O2CFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
FELODIPINEACTIVE MOIETYOL961R6O2CFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
KAOLININACTIVE INGREDIENT24H4NWX5COFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8FFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-233FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]6Current NDC, Legacy NDC, 5 package rows20181219_2e4298cf-02e9-49c7-9803-887161e1989a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402695felodipine 10 MG 24HR Extended Release Oral TabletPSN2e4298cf-02e9-49c7-9803-887161e1989a7
402698felodipine 2.5 MG 24HR Extended Release Oral TabletPSN2e4298cf-02e9-49c7-9803-887161e1989a7
402696felodipine 5 MG 24HR Extended Release Oral TabletPSN2e4298cf-02e9-49c7-9803-887161e1989a7
40269524 HR felodipine 10 MG Extended Release Oral TabletSCD2e4298cf-02e9-49c7-9803-887161e1989a7
40269824 HR felodipine 2.5 MG Extended Release Oral TabletSCD2e4298cf-02e9-49c7-9803-887161e1989a7
40269624 HR felodipine 5 MG Extended Release Oral TabletSCD2e4298cf-02e9-49c7-9803-887161e1989a7
402695felodipine 10 MG 24 HR Extended Release Oral TabletSY2e4298cf-02e9-49c7-9803-887161e1989a7
402698felodipine 2.5 MG 24 HR Extended Release Oral TabletSY2e4298cf-02e9-49c7-9803-887161e1989a7
402696felodipine 5 MG 24 HR Extended Release Oral TabletSY2e4298cf-02e9-49c7-9803-887161e1989a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-233-0168462023301100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-233-01) 2010-12-200000-00-00NoNoCurrent
68462-233-10684620233101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-233-10) 2010-12-200000-00-00NoNoCurrent
68462-233-116846202331110 BLISTER PACK in 1 CARTON (68462-233-11) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2010-12-200000-00-00NoNoCurrent
68462-233-906846202339090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-233-90) 2010-12-200000-00-00NoNoCurrent