FDA.reportPublic FDA data

Felodipine

Product NDC
57237-108
11-digit product format
572370108
Labeler code
57237
Product ID
57237-108_9ea82ae9-2d77-4da4-8213-dda2434df9d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felodipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
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
57237-108-01Felodipine100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-108-01EA - Each57237-1080b49264d-c97d-4184-a7f4-2efea898872e12015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FELODIPINEACTIVE INGREDIENTOL961R6O2CFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
FELODIPINEACTIVE MOIETYOL961R6O2CFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
ALUMINUM SILICATEINACTIVE INGREDIENTT1FAD4SS2MFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8FFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [CITRON PHARMA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-108FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.]6Current NDC, Legacy NDC, 1 package rows20240222_f5f56c59-04d5-4c5d-9441-5a93d3bdec82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402695felodipine 10 MG 24HR Extended Release Oral TabletPSNf5f56c59-04d5-4c5d-9441-5a93d3bdec826
402698felodipine 2.5 MG 24HR Extended Release Oral TabletPSNf5f56c59-04d5-4c5d-9441-5a93d3bdec826
402696felodipine 5 MG 24HR Extended Release Oral TabletPSNf5f56c59-04d5-4c5d-9441-5a93d3bdec826
40269524 HR felodipine 10 MG Extended Release Oral TabletSCDf5f56c59-04d5-4c5d-9441-5a93d3bdec826
40269824 HR felodipine 2.5 MG Extended Release Oral TabletSCDf5f56c59-04d5-4c5d-9441-5a93d3bdec826
40269624 HR felodipine 5 MG Extended Release Oral TabletSCDf5f56c59-04d5-4c5d-9441-5a93d3bdec826
402695felodipine 10 MG 24 HR Extended Release Oral TabletSYf5f56c59-04d5-4c5d-9441-5a93d3bdec826
402698felodipine 2.5 MG 24 HR Extended Release Oral TabletSYf5f56c59-04d5-4c5d-9441-5a93d3bdec826
402696felodipine 5 MG 24 HR Extended Release Oral TabletSYf5f56c59-04d5-4c5d-9441-5a93d3bdec826

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-108-0157237010801100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-108-01) 2013-01-170000-00-00NoNoCurrent