Felodipine

Product NDC
63629-2192
11-digit product format
636292192
Labeler code
63629
Product ID
63629-2192_991e9e9a-9ec7-46f2-91e5-772f3c156aa7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felodipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200815
Marketing category
ANDA
Marketing start
2011-12-15
Substance
FELODIPINE
Active strength
10 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
FELODIPINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOL961R6O2C
Rxcui402695

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
63629-2192-1Felodipine500 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE500104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2192-1EA - Each63629-219226b6e955-b708-4ae6-b7ed-77abad95ac9512021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2192FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20241219_9b6deb61-f94e-4b21-adc9-37a1d188c9bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402695felodipine 10 MG 24HR Extended Release Oral TabletPSN9b6deb61-f94e-4b21-adc9-37a1d188c9bd104
40269524 HR felodipine 10 MG Extended Release Oral TabletSCD9b6deb61-f94e-4b21-adc9-37a1d188c9bd104
402695felodipine 10 MG 24 HR Extended Release Oral TabletSY9b6deb61-f94e-4b21-adc9-37a1d188c9bd104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2192-163629219201500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-2192-1) 2011-12-150000-00-00NoNoCurrent