Felodipine

Product NDC
69367-264
11-digit product format
693670264
Labeler code
69367
Product ID
69367-264_51791555-1064-4991-b58c-3a37ce596d60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felodipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA210847
Marketing category
ANDA
Marketing start
2023-03-31
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
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
69367-264-01Felodipine100 in 1 BOTTLETABLET, EXTENDED RELEASE1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-264FELODIPINE TABLET, EXTENDED RELEASE FELOPDIPINE (FELODIPINE) TABLET, EXTENDED RELEASE [WESTMINSTER PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20230414_a6560584-e39f-47b3-84db-95da1f90fd40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402695felodipine 10 MG 24HR Extended Release Oral TabletPSNa6560584-e39f-47b3-84db-95da1f90fd401
402698felodipine 2.5 MG 24HR Extended Release Oral TabletPSNa6560584-e39f-47b3-84db-95da1f90fd401
402696felodipine 5 MG 24HR Extended Release Oral TabletPSNa6560584-e39f-47b3-84db-95da1f90fd401
40269524 HR felodipine 10 MG Extended Release Oral TabletSCDa6560584-e39f-47b3-84db-95da1f90fd401
40269824 HR felodipine 2.5 MG Extended Release Oral TabletSCDa6560584-e39f-47b3-84db-95da1f90fd401
40269624 HR felodipine 5 MG Extended Release Oral TabletSCDa6560584-e39f-47b3-84db-95da1f90fd401
402695felodipine 10 MG 24 HR Extended Release Oral TabletSYa6560584-e39f-47b3-84db-95da1f90fd401
402698felodipine 2.5 MG 24 HR Extended Release Oral TabletSYa6560584-e39f-47b3-84db-95da1f90fd401
402696felodipine 5 MG 24 HR Extended Release Oral TabletSYa6560584-e39f-47b3-84db-95da1f90fd401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69367-264-0169367026401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-264-01) 2023-03-31NoNoCurrent