FDA.reportPublic FDA data

Felodipine

Product NDC
72162-1160
11-digit product format
721621160
Labeler code
72162
Product ID
72162-1160_ed9ee5b6-5cf9-45bb-b321-74c902baf333
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
72162-1160-1Felodipine100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE100100
72162-1160-5Felodipine500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE500100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1160-1EA - Each72162-11604bf7e787-2216-44e0-acc6-c38e092b23ac12023-05-05
72162-1160-5EA - Each72162-1160c394e174-e1c9-4006-b04c-48925aff60a012023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1160FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20230401_196ef773-8a2a-4ef7-a403-2341f94f4d98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402695felodipine 10 MG 24HR Extended Release Oral TabletPSN196ef773-8a2a-4ef7-a403-2341f94f4d98100
40269524 HR felodipine 10 MG Extended Release Oral TabletSCD196ef773-8a2a-4ef7-a403-2341f94f4d98100
402695felodipine 10 MG 24 HR Extended Release Oral TabletSY196ef773-8a2a-4ef7-a403-2341f94f4d98100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1160-172162116001100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72162-1160-1) 2023-03-30NoNoHistorical
72162-1160-572162116005500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72162-1160-5) 2023-03-30NoNoHistorical