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

openFDA Listing Details

Product ID
71335-1318_308642fc-50f9-4828-9f7f-95375a26cf10
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Felodipine
Generic name
Felodipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Marketing start
2013-01-17
Marketing category
ANDA
Application number
ANDA203417
Pharmacologic classes
Calcium Channel Antagonists [MoA]; Dihydropyridine Calcium Channel Blocker [EPC]; Dihydropyridines [CS]
Listing expiration
2026-12-31

Related Records

openFDA Active Ingredients

IngredientStrength
FELODIPINE5 mg/1

openFDA Harmonized Identifiers

FieldValues
UniiOL961R6O2C
Rxcui402696
Spl Set Id8eadbf3d-c93b-431c-aa86-559fc2a1d5a8
Manufacturer NameBryant Ranch Prepack

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
OL961R6O2CFELODIPINE72509-76-3FELODIPINE

Packages

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

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Felodipine Extended-Release Tablets, USP Rx onlyBryant Ranch Prepack2024-04-03HUMAN PRESCRIPTION DRUG LABEL5