FDA.reportPublic FDA data

FELODIPINE

Product NDC
23155-048
11-digit product format
231550048
Labeler code
23155
Product ID
23155-048_c39f92ed-6e77-4742-b4e4-deec031f1e31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FELODIPINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA201964
Marketing category
ANDA
Marketing start
2013-11-08
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
23155-048-01FELODIPINE100 in 1 BOTTLETABLET, EXTENDED RELEASE1007
23155-048-05FELODIPINE100 in 1 BOTTLETABLET, EXTENDED RELEASE1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-048-01EA - Each23155-048505ac9e9-cd9a-4a26-8fac-ef7a82a72fb712015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FELODIPINEACTIVE INGREDIENTOL961R6O2CFELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]2
FELODIPINEACTIVE MOIETYOL961R6O2CFELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PFELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]2
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2FELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4FELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]2
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCFELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]2
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8FFELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]2
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIFELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-048FELODIPINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 2 package rows20230721_0bef7cf2-012b-4804-ac93-0a8b333035db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402695felodipine 10 MG 24HR Extended Release Oral TabletPSN0bef7cf2-012b-4804-ac93-0a8b333035db7
402698felodipine 2.5 MG 24HR Extended Release Oral TabletPSN0bef7cf2-012b-4804-ac93-0a8b333035db7
402696felodipine 5 MG 24HR Extended Release Oral TabletPSN0bef7cf2-012b-4804-ac93-0a8b333035db7
40269524 HR felodipine 10 MG Extended Release Oral TabletSCD0bef7cf2-012b-4804-ac93-0a8b333035db7
40269824 HR felodipine 2.5 MG Extended Release Oral TabletSCD0bef7cf2-012b-4804-ac93-0a8b333035db7
40269624 HR felodipine 5 MG Extended Release Oral TabletSCD0bef7cf2-012b-4804-ac93-0a8b333035db7
402695felodipine 10 MG 24 HR Extended Release Oral TabletSY0bef7cf2-012b-4804-ac93-0a8b333035db7
402698felodipine 2.5 MG 24 HR Extended Release Oral TabletSY0bef7cf2-012b-4804-ac93-0a8b333035db7
402696felodipine 5 MG 24 HR Extended Release Oral TabletSY0bef7cf2-012b-4804-ac93-0a8b333035db7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
23155-048-0123155004801100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-048-01) 2013-11-080000-00-00NoNoCurrent
23155-048-0523155004805100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-048-05) 2013-11-080000-00-00NoNoCurrent