FDA.reportPublic FDA data

Felodipine

Product NDC
65862-673
11-digit product format
658620673
Labeler code
65862
Product ID
65862-673_a8579789-363a-44b3-be60-fe7bad9b16a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felodipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA203417
Marketing category
ANDA
Marketing start
2013-01-17
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Felodipine
Listing expiration
2026-12-31

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
65862-673-01Felodipine100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1004
65862-673-10Felodipine10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE104
65862-673-78Felodipine10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE104
65862-673-90Felodipine90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE904
65862-673-99Felodipine1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-673FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]4Current NDC, Legacy NDC, 5 package rows20240218_dd39c559-5c5d-4d3b-9228-c44085e1699f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402695felodipine 10 MG 24HR Extended Release Oral TabletPSNdd39c559-5c5d-4d3b-9228-c44085e1699f4
402698felodipine 2.5 MG 24HR Extended Release Oral TabletPSNdd39c559-5c5d-4d3b-9228-c44085e1699f4
402696felodipine 5 MG 24HR Extended Release Oral TabletPSNdd39c559-5c5d-4d3b-9228-c44085e1699f4
40269524 HR felodipine 10 MG Extended Release Oral TabletSCDdd39c559-5c5d-4d3b-9228-c44085e1699f4
40269824 HR felodipine 2.5 MG Extended Release Oral TabletSCDdd39c559-5c5d-4d3b-9228-c44085e1699f4
40269624 HR felodipine 5 MG Extended Release Oral TabletSCDdd39c559-5c5d-4d3b-9228-c44085e1699f4
402695felodipine 10 MG 24 HR Extended Release Oral TabletSYdd39c559-5c5d-4d3b-9228-c44085e1699f4
402698felodipine 2.5 MG 24 HR Extended Release Oral TabletSYdd39c559-5c5d-4d3b-9228-c44085e1699f4
402696felodipine 5 MG 24 HR Extended Release Oral TabletSYdd39c559-5c5d-4d3b-9228-c44085e1699f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-673-0165862067301100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-673-01) 2013-01-170000-00-00NoNoCurrent
65862-673-106586206731010 in 1 BLISTER PACKHistorical
65862-673-22658620673222000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BAG (65862-673-22)17-JAN-13Current
65862-673-786586206737810 BLISTER PACK in 1 CARTON (65862-673-78) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (65862-673-10) 10 blister pack2013-01-170000-00-00NoNoCurrent
65862-673-906586206739090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-673-90) 2013-01-170000-00-00NoNoCurrent
65862-673-99658620673991000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-673-99) 2013-01-170000-00-00NoNoCurrent