FDA.reportPublic FDA data

Felodipine

Product NDC
71205-921
11-digit product format
712050921
Labeler code
71205
Product ID
71205-921_06c9bc5a-7a0f-483d-bd5c-61768db340bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felodipine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204800
Marketing category
ANDA
Marketing start
2020-10-12
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
71205-921-00Felodipine100 in 1 BOTTLETABLET, FILM COATED1002
71205-921-30Felodipine30 in 1 BOTTLETABLET, FILM COATED302
71205-921-55Felodipine500 in 1 BOTTLETABLET, FILM COATED5002
71205-921-60Felodipine60 in 1 BOTTLETABLET, FILM COATED602
71205-921-72Felodipine120 in 1 BOTTLETABLET, FILM COATED1202
71205-921-90Felodipine90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-921-00EA - Each71205-921fc45d743-f84a-4f28-b25f-db1494f2b13d12021-08-05
71205-921-30EA - Each71205-9211746036a-7594-45bc-b932-847b856191a012021-08-05
71205-921-55EA - Each71205-921625fb7b8-7920-490b-824e-d06c6a99cb9312021-08-05
71205-921-60EA - Each71205-92161be930e-c6be-4c6c-9bc6-c0a3a62dc54512021-08-05
71205-921-72EA - Each71205-921040a1a07-044e-447c-9029-e19634d6b17a12021-08-05
71205-921-90EA - Each71205-921232b89d9-b21a-4caa-83c8-dc631cef418312021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-921FELODIPINE TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 6 package rows20220420_2c4dd9a4-61ca-4c88-90f6-12d9e0fdb7cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
71205-921-0071205092100100 TABLET, FILM COATED in 1 BOTTLE (71205-921-00) 2021-06-180000-00-00NoNoCurrent
71205-921-307120509213030 TABLET, FILM COATED in 1 BOTTLE (71205-921-30) 2021-06-180000-00-00NoNoCurrent
71205-921-5571205092155500 TABLET, FILM COATED in 1 BOTTLE (71205-921-55) 2021-06-180000-00-00NoNoCurrent
71205-921-607120509216060 TABLET, FILM COATED in 1 BOTTLE (71205-921-60) 2021-06-180000-00-00NoNoCurrent
71205-921-7271205092172120 TABLET, FILM COATED in 1 BOTTLE (71205-921-72) 2021-06-180000-00-00NoNoCurrent
71205-921-907120509219090 TABLET, FILM COATED in 1 BOTTLE (71205-921-90) 2021-06-180000-00-00NoNoCurrent