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NDC 43376-0322-30 Fintepla 2.2 mg/mL Details
Fintepla 2.2 mg/mL
Fintepla is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by UCB, Inc.. The primary component is FENFLURAMINE.
MedlinePlus Drug Summary
Fenfluramine is used to control seizures in children from 2 years of age and older with Dravet syndrome (a disorder that begins in early childhood and causes seizures and later may lead to developmental delays and changes in eating, balance, and walking) and Lennox-Gastaut syndrome (LGS) (a disorder that causes seizures and developmental delays). Fenfluramine is in a class of medications called anticonvulsants. It is not known exactly how fenfluramine works, but it increases the amount of natural substances in the brain that may reduce seizure activity.
Related Packages: 43376-0322-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fenfluramine
Product Information
| NDC | 43376-0322 |
|---|---|
| Product ID | 43376-322_5dc79cac-29be-48b8-9dd1-0613731abc9d |
| Associated GPIs | 72600028102020 |
| GCN Sequence Number | 081237 |
| GCN Sequence Number Description | fenfluramine HCl SOLUTION 2.2 MG/ML ORAL |
| HIC3 | H4B |
| HIC3 Description | ANTICONVULSANTS |
| GCN | 48284 |
| HICL Sequence Number | 002116 |
| HICL Sequence Number Description | FENFLURAMINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | Fintepla |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | fenfluramine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 2.2 |
| Active Ingredient Units | mg/mL |
| Substance Name | FENFLURAMINE |
| Labeler Name | UCB, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA212102 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43376-0322-30 (43376032230)
| NDC Package Code | 43376-322-30 |
|---|---|
| Billing NDC | 43376032230 |
| Package | 1 BOTTLE, PLASTIC in 1 CARTON (43376-322-30) / 30 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2020-07-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |