FDA.reportPublic FDA data

Felodipine

Product NDC
69117-0030
11-digit product format
691170030
Labeler code
69117
Product ID
69117-0030_47236bb3-7d75-0c2a-e063-6394a90a7ac7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felodipine Extended-release Tablets
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Yiling Pharmaceutical Inc.
Application
ANDA210847
Marketing category
ANDA
Marketing start
2019-08-01
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, 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
69117-0030-1Felodipine100 in 1 BOTTLETABLET, EXTENDED RELEASE1007
69117-0030-2Felodipine500 in 1 BOTTLETABLET, EXTENDED RELEASE5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69117-0030-1EA - Each69117-003057fcb5fd-9b55-40e6-8d9b-3c2f1a2b0cd412019-03-12
69117-0030-2EA - Each69117-003065f7e232-bf82-4cec-a17d-5e012f3a93bc12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69117-0030FELODIPINE (FELODIPINE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [YILING PHARMACEUTICAL INC.]6Current NDC, Legacy NDC, 2 package rows20250101_7990a581-3e0f-5d8c-e053-2991aa0aa6a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402695felodipine 10 MG 24HR Extended Release Oral TabletPSN7990a581-3e0f-5d8c-e053-2991aa0aa6a77
402698felodipine 2.5 MG 24HR Extended Release Oral TabletPSN7990a581-3e0f-5d8c-e053-2991aa0aa6a77
402696felodipine 5 MG 24HR Extended Release Oral TabletPSN7990a581-3e0f-5d8c-e053-2991aa0aa6a77
40269524 HR felodipine 10 MG Extended Release Oral TabletSCD7990a581-3e0f-5d8c-e053-2991aa0aa6a77
40269824 HR felodipine 2.5 MG Extended Release Oral TabletSCD7990a581-3e0f-5d8c-e053-2991aa0aa6a77
40269624 HR felodipine 5 MG Extended Release Oral TabletSCD7990a581-3e0f-5d8c-e053-2991aa0aa6a77
402695felodipine 10 MG 24 HR Extended Release Oral TabletSY7990a581-3e0f-5d8c-e053-2991aa0aa6a77
402698felodipine 2.5 MG 24 HR Extended Release Oral TabletSY7990a581-3e0f-5d8c-e053-2991aa0aa6a77
402696felodipine 5 MG 24 HR Extended Release Oral TabletSY7990a581-3e0f-5d8c-e053-2991aa0aa6a77
402695felodipine 10 MG 24HR Extended Release Oral TabletPSNe7c2a381-3adf-455b-bbb7-8d557ed9349f3
40269524 HR felodipine 10 MG Extended Release Oral TabletSCDe7c2a381-3adf-455b-bbb7-8d557ed9349f3
402695felodipine 10 MG 24 HR Extended Release Oral TabletSYe7c2a381-3adf-455b-bbb7-8d557ed9349f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69117-0030-169117003001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69117-0030-1) 2019-08-010000-00-00NoNoCurrent
69117-0030-269117003002500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69117-0030-2) 2019-08-010000-00-00NoNoCurrent