Felodipine

Product NDC
71335-1318
11-digit product format
713351318
Labeler code
71335
Product ID
71335-1318_308642fc-50f9-4828-9f7f-95375a26cf10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felodipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203417
Marketing category
ANDA
Marketing start
2013-01-17
Substance
FELODIPINE
Active strength
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
FELODIPINE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOL961R6O2C
Rxcui402696

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
71335-1318-1Felodipine30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1318FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 1 package rows20240407_8eadbf3d-c93b-431c-aa86-559fc2a1d5a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402696felodipine 5 MG 24HR Extended Release Oral TabletPSN8eadbf3d-c93b-431c-aa86-559fc2a1d5a85
40269624 HR felodipine 5 MG Extended Release Oral TabletSCD8eadbf3d-c93b-431c-aa86-559fc2a1d5a85
402696felodipine 5 MG 24 HR Extended Release Oral TabletSY8eadbf3d-c93b-431c-aa86-559fc2a1d5a85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1318-17133513180130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1318-1) 2019-08-270000-00-00NoNoCurrent