Felodipine

Product NDC
63629-2196
11-digit product format
636292196
Labeler code
63629
Product ID
63629-2196_478abcc5-1f40-455b-a479-c277d6e1de53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felodipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200815
Marketing category
ANDA
Marketing start
2011-12-15
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

Additional Listing Data#

Finished product
Yes
Brand name base
Felodipine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FELODIPINE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOL961R6O2C
Rxcui402696

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
63629-2196-1Felodipine500 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE500104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2196-1EA - Each63629-2196435acaf9-e605-4dff-9203-9b7a3d0de17412021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2196FELODIPINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20241219_b27a13d4-c068-43c8-b654-b8b3276e468a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402696felodipine 5 MG 24HR Extended Release Oral TabletPSNb27a13d4-c068-43c8-b654-b8b3276e468a104
40269624 HR felodipine 5 MG Extended Release Oral TabletSCDb27a13d4-c068-43c8-b654-b8b3276e468a104
402696felodipine 5 MG 24 HR Extended Release Oral TabletSYb27a13d4-c068-43c8-b654-b8b3276e468a104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2196-163629219601500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-2196-1) 2011-12-150000-00-00NoNoCurrent