FDA.reportPublic FDA data

Felodipine

Product NDC
61442-431
11-digit product format
614420431
Labeler code
61442
Product ID
61442-431_2e6e562c-bff2-1d2f-e063-6394a90a5001
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felodipine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Carlsbad Technology, Inc.
Application
ANDA204800
Marketing category
ANDA
Marketing start
2020-10-12
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
61442-431-01Felodipine100 in 1 BOTTLETABLET, FILM COATED1006
61442-431-05Felodipine500 in 1 BOTTLETABLET, FILM COATED5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61442-431-05EA - Each61442-43197e7980c-b7ea-4c2b-bf9b-7184e51e2e1d12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61442-431FELODIPINE TABLET, FILM COATED [CARLSBAD TECHNOLOGY, INC.]6Current NDC, Legacy NDC, 2 package rows20250221_7bd4fa00-f0d8-4aea-9c24-a799b05e60e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402698felodipine 2.5 MG 24HR Extended Release Oral TabletPSN5c7b7f9a-4f4c-4259-8aae-fdb91ab09eec104
40269824 HR felodipine 2.5 MG Extended Release Oral TabletSCD5c7b7f9a-4f4c-4259-8aae-fdb91ab09eec104
402698felodipine 2.5 MG 24 HR Extended Release Oral TabletSY5c7b7f9a-4f4c-4259-8aae-fdb91ab09eec104
402698felodipine 2.5 MG 24HR Extended Release Oral TabletPSN063e633b-03ca-46e2-b6a0-8a300fccee93101
40269824 HR felodipine 2.5 MG Extended Release Oral TabletSCD063e633b-03ca-46e2-b6a0-8a300fccee93101
402698felodipine 2.5 MG 24 HR Extended Release Oral TabletSY063e633b-03ca-46e2-b6a0-8a300fccee93101
402695felodipine 10 MG 24HR Extended Release Oral TabletPSNbdd41c3a-c537-02f3-e053-2995a90a89297
402698felodipine 2.5 MG 24HR Extended Release Oral TabletPSNbdd41c3a-c537-02f3-e053-2995a90a89297
402696felodipine 5 MG 24HR Extended Release Oral TabletPSNbdd41c3a-c537-02f3-e053-2995a90a89297
40269524 HR felodipine 10 MG Extended Release Oral TabletSCDbdd41c3a-c537-02f3-e053-2995a90a89297
40269824 HR felodipine 2.5 MG Extended Release Oral TabletSCDbdd41c3a-c537-02f3-e053-2995a90a89297
40269624 HR felodipine 5 MG Extended Release Oral TabletSCDbdd41c3a-c537-02f3-e053-2995a90a89297
402695felodipine 10 MG 24 HR Extended Release Oral TabletSYbdd41c3a-c537-02f3-e053-2995a90a89297
402698felodipine 2.5 MG 24 HR Extended Release Oral TabletSYbdd41c3a-c537-02f3-e053-2995a90a89297
402696felodipine 5 MG 24 HR Extended Release Oral TabletSYbdd41c3a-c537-02f3-e053-2995a90a89297
402695felodipine 10 MG 24HR Extended Release Oral TabletPSN7bd4fa00-f0d8-4aea-9c24-a799b05e60e16
402698felodipine 2.5 MG 24HR Extended Release Oral TabletPSN7bd4fa00-f0d8-4aea-9c24-a799b05e60e16
402696felodipine 5 MG 24HR Extended Release Oral TabletPSN7bd4fa00-f0d8-4aea-9c24-a799b05e60e16
40269524 HR felodipine 10 MG Extended Release Oral TabletSCD7bd4fa00-f0d8-4aea-9c24-a799b05e60e16
40269824 HR felodipine 2.5 MG Extended Release Oral TabletSCD7bd4fa00-f0d8-4aea-9c24-a799b05e60e16
40269624 HR felodipine 5 MG Extended Release Oral TabletSCD7bd4fa00-f0d8-4aea-9c24-a799b05e60e16
402695felodipine 10 MG 24 HR Extended Release Oral TabletSY7bd4fa00-f0d8-4aea-9c24-a799b05e60e16
402698felodipine 2.5 MG 24 HR Extended Release Oral TabletSY7bd4fa00-f0d8-4aea-9c24-a799b05e60e16
402696felodipine 5 MG 24 HR Extended Release Oral TabletSY7bd4fa00-f0d8-4aea-9c24-a799b05e60e16
402695felodipine 10 MG 24HR Extended Release Oral TabletPSN2c4dd9a4-61ca-4c88-90f6-12d9e0fdb7cd2
402698felodipine 2.5 MG 24HR Extended Release Oral TabletPSN2c4dd9a4-61ca-4c88-90f6-12d9e0fdb7cd2
402696felodipine 5 MG 24HR Extended Release Oral TabletPSN2c4dd9a4-61ca-4c88-90f6-12d9e0fdb7cd2
40269524 HR felodipine 10 MG Extended Release Oral TabletSCD2c4dd9a4-61ca-4c88-90f6-12d9e0fdb7cd2
40269824 HR felodipine 2.5 MG Extended Release Oral TabletSCD2c4dd9a4-61ca-4c88-90f6-12d9e0fdb7cd2
40269624 HR felodipine 5 MG Extended Release Oral TabletSCD2c4dd9a4-61ca-4c88-90f6-12d9e0fdb7cd2
402695felodipine 10 MG 24 HR Extended Release Oral TabletSY2c4dd9a4-61ca-4c88-90f6-12d9e0fdb7cd2
402698felodipine 2.5 MG 24 HR Extended Release Oral TabletSY2c4dd9a4-61ca-4c88-90f6-12d9e0fdb7cd2
402696felodipine 5 MG 24 HR Extended Release Oral TabletSY2c4dd9a4-61ca-4c88-90f6-12d9e0fdb7cd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61442-431-0161442043101100 TABLET, FILM COATED in 1 BOTTLE (61442-431-01) 2020-10-120000-00-00NoNoCurrent
61442-431-0561442043105500 TABLET, FILM COATED in 1 BOTTLE (61442-431-05) 2020-10-120000-00-00NoNoCurrent