FDA.reportPublic FDA data

Felodipine

Product NDC
72162-1158
11-digit product format
721621158
Labeler code
72162
Product ID
72162-1158_11dbb480-9f25-4185-a41f-512c0ecab534
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
2009-03-31
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
Rxcui402698

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
72162-1158-1Felodipine100 in 1 BOTTLETABLET, EXTENDED RELEASE100100
72162-1158-5Felodipine500 in 1 BOTTLETABLET, EXTENDED RELEASE500100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1158-1EA - Each72162-115811aec012-d504-40e6-92ce-3cf6e4a4d47812023-05-05
72162-1158-5EA - Each72162-11583cdc3822-087d-4b8d-9fbd-5503169c66f912023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1158FELODIPINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20230401_30d15f4b-a0ee-4841-ace3-dcaf52016953.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402698felodipine 2.5 MG 24HR Extended Release Oral TabletPSN30d15f4b-a0ee-4841-ace3-dcaf52016953100
40269824 HR felodipine 2.5 MG Extended Release Oral TabletSCD30d15f4b-a0ee-4841-ace3-dcaf52016953100
402698felodipine 2.5 MG 24 HR Extended Release Oral TabletSY30d15f4b-a0ee-4841-ace3-dcaf52016953100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1158-172162115801100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-1158-1) 2023-03-30NoNoCurrent
72162-1158-572162115805500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-1158-5) 2023-03-30NoNoCurrent