fintepla

Generic: fenfluramine

Labeler: ucb, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name fintepla
Generic Name fenfluramine
Labeler ucb, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

fenfluramine 2.2 mg/mL

Manufacturer
UCB, Inc.

Identifiers & Regulatory

Product NDC 43376-322
Product ID 43376-322_42264a61-0fc3-3a99-e063-6294a90a9595
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212102
Listing Expiration 2026-12-31
Marketing Start 2020-07-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43376322
Hyphenated Format 43376-322

Supplemental Identifiers

RxCUI
2381138 2381144
UNII
2DS058H2CF

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fintepla (source: ndc)
Generic Name fenfluramine (source: ndc)
Application Number NDA212102 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.2 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (43376-322-30) / 30 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (43376-322-36) / 360 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

43376-322-30 1 BOTTLE, PLASTIC in 1 CARTON (43376-322-30) / 30 mL in 1 BOTTLE, PLASTIC 43376-322-36 1 BOTTLE, PLASTIC in 1 CARTON (43376-322-36) / 360 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

fenfluramine (2.2 mg/mL)

Linked Drug Pages (1)

Fintepla ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "42264a61-0fc3-3a99-e063-6294a90a9595", "openfda": {"unii": ["2DS058H2CF"], "rxcui": ["2381138", "2381144"], "spl_set_id": ["e88f360e-33ad-4cd6-b2de-5ef885857c5d"], "manufacturer_name": ["UCB, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (43376-322-30)  / 30 mL in 1 BOTTLE, PLASTIC", "package_ndc": "43376-322-30", "marketing_start_date": "20200715"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (43376-322-36)  / 360 mL in 1 BOTTLE, PLASTIC", "package_ndc": "43376-322-36", "marketing_start_date": "20200715"}], "brand_name": "Fintepla", "product_id": "43376-322_42264a61-0fc3-3a99-e063-6294a90a9595", "dosage_form": "SOLUTION", "product_ndc": "43376-322", "generic_name": "fenfluramine", "labeler_name": "UCB, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fintepla", "active_ingredients": [{"name": "FENFLURAMINE", "strength": "2.2 mg/mL"}], "application_number": "NDA212102", "marketing_category": "NDA", "marketing_start_date": "20200715", "listing_expiration_date": "20261231"}