FDA.reportPublic FDA data

Fintepla

Product NDC
43376-322
11-digit product format
433760322
Labeler code
43376
Product ID
43376-322_42264a61-0fc3-3a99-e063-6294a90a9595
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fenfluramine
Dosage form
SOLUTION
Route
ORAL
Labeler
UCB, Inc.
Application
NDA212102
Marketing category
NDA
Marketing start
2020-07-15
Substance
FENFLURAMINE
Active strength
2.2 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fintepla
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENFLURAMINE2.2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2DS058H2CF
Rxcui2381138, 2381144

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
81df8660-012c-4e56-acc7-5657fa943fc2Product name120210115

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43376-322-30Fintepla30 mL in 1 BOTTLE, PLASTICSOLUTION3016
43376-322-30Fintepla1 in 1 CARTONSOLUTION116
43376-322-36Fintepla360 mL in 1 BOTTLE, PLASTICSOLUTION36016
43376-322-36Fintepla1 in 1 CARTONSOLUTION116

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43376-322FINTEPLA (FENFLURAMINE) SOLUTION [UCB, INC.]14Current NDC, Legacy NDC, 4 package rows20250418_e88f360e-33ad-4cd6-b2de-5ef885857c5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2381138fenfluramine 2.2 MG/mL Oral SolutionPSNe88f360e-33ad-4cd6-b2de-5ef885857c5d16
2381144Fintepla 2.2 MG/mL Oral SolutionPSNe88f360e-33ad-4cd6-b2de-5ef885857c5d16
2381144fenfluramine 2.2 MG/ML Oral Solution [Fintepla]SBDe88f360e-33ad-4cd6-b2de-5ef885857c5d16
2381138fenfluramine 2.2 MG/ML Oral SolutionSCDe88f360e-33ad-4cd6-b2de-5ef885857c5d16
2381138fenfluramine 2.2 MG/ML (as fenfluramine HCl 2.5 MG/ML) Oral SolutionSYe88f360e-33ad-4cd6-b2de-5ef885857c5d16
2381144fenfluramine 2.2 MG/ML (as fenfluramine HCl 2.5 MG/ML) Oral Solution [Fintepla]SYe88f360e-33ad-4cd6-b2de-5ef885857c5d16
2381144Fintepla 2.2 MG/ML Oral SolutionSYe88f360e-33ad-4cd6-b2de-5ef885857c5d16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43376-322-30433760322301 BOTTLE, PLASTIC in 1 CARTON (43376-322-30) / 30 mL in 1 BOTTLE, PLASTIC2020-07-150000-00-00NoNoCurrent
43376-322-36433760322361 BOTTLE, PLASTIC in 1 CARTON (43376-322-36) / 360 mL in 1 BOTTLE, PLASTIC2020-07-150000-00-00NoNoCurrent