FDA.reportPublic FDA data

Felodipine

Product NDC
62135-646
11-digit product format
621350646
Labeler code
62135
Product ID
62135-646_459bc915-c26d-844b-e063-6394a90a5c13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felodipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA210847
Marketing category
ANDA
Marketing start
2019-08-01
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
62135-646-90Felodipine90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-646-90EA - Each62135-64696a30e88-fdc2-4856-ba39-3654eba1836912023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-646FELODIPINE TABLET, EXTENDED RELEASE [CHARTWELL RX, LLC]2Current NDC, 1 package rows20241030_fddebfce-70ed-4ee1-8598-bbb8f1ca9263.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402695felodipine 10 MG 24HR Extended Release Oral TabletPSNfddebfce-70ed-4ee1-8598-bbb8f1ca92633
402698felodipine 2.5 MG 24HR Extended Release Oral TabletPSNfddebfce-70ed-4ee1-8598-bbb8f1ca92633
402696felodipine 5 MG 24HR Extended Release Oral TabletPSNfddebfce-70ed-4ee1-8598-bbb8f1ca92633
40269524 HR felodipine 10 MG Extended Release Oral TabletSCDfddebfce-70ed-4ee1-8598-bbb8f1ca92633
40269824 HR felodipine 2.5 MG Extended Release Oral TabletSCDfddebfce-70ed-4ee1-8598-bbb8f1ca92633
40269624 HR felodipine 5 MG Extended Release Oral TabletSCDfddebfce-70ed-4ee1-8598-bbb8f1ca92633
402695felodipine 10 MG 24 HR Extended Release Oral TabletSYfddebfce-70ed-4ee1-8598-bbb8f1ca92633
402698felodipine 2.5 MG 24 HR Extended Release Oral TabletSYfddebfce-70ed-4ee1-8598-bbb8f1ca92633
402696felodipine 5 MG 24 HR Extended Release Oral TabletSYfddebfce-70ed-4ee1-8598-bbb8f1ca92633

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62135-646-906213506469090 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-646-90) 2023-06-05NoNoHistorical