FDA.reportPublic FDA data

Felodipine

Product NDC
51407-088
11-digit product format
514070088
Labeler code
51407
Product ID
51407-088_2ee8e77f-f743-bfc9-e063-6394a90a1bd6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felodipine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA204800
Marketing category
ANDA
Marketing start
2019-04-29
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
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
51407-088-01Felodipine100 in 1 BOTTLETABLET, FILM COATED1007
51407-088-05Felodipine500 in 1 BOTTLETABLET, FILM COATED5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-088-01EA - Each51407-088615d793c-2396-4f08-98b3-81166aef6e9512021-04-08
51407-088-05EA - Each51407-08838d2ff20-28c2-4d33-9220-0a99bc35093312021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-088FELODIPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]7Current NDC, Legacy NDC, 2 package rows20250411_bdd41c3a-c537-02f3-e053-2995a90a8929.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-088-0151407008801100 TABLET, FILM COATED in 1 BOTTLE (51407-088-01) 2020-03-130000-00-00NoNoCurrent
51407-088-0551407008805500 TABLET, FILM COATED in 1 BOTTLE (51407-088-05) 2020-03-130000-00-00NoNoCurrent