Prescription drug · NDA
Fintepla (Fenfluramine) NDC 43376-322
Fenfluramine 2.2 mg/mL · Solution · Oral · UCB, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43376-322-30 | 43376032230 | 1 BOTTLE, PLASTIC in 1 CARTON (43376-322-30) / 30 mL in 1 BOTTLE, PLASTICMarketed from Jul 15, 2020 | |
| 43376-322-36 | 43376032236 | 1 BOTTLE, PLASTIC in 1 CARTON (43376-322-36) / 360 mL in 1 BOTTLE, PLASTICMarketed from Jul 15, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Fintepla
- Generic name (nonproprietary)
- fenfluramine
- Active ingredients
- Fenfluramine — 2.2 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- UCB, Inc.NDC labeler code 43376
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212102
- Marketing start
- Listing expires
- Identifiers
- Product ID 43376-322_42264a61-0fc3-3a99-e063-6294a90a9595SPL ID 42264a61-0fc3-3a99-e063-6294a90a9595SPL set ID e88f360e-33ad-4cd6-b2de-5ef885857c5dRxCUI 2381138, 2381144UNII 2DS058H2CF
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N443376032230followed by a unit qualifier and the quantityPackage 43376-0322-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
FINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older. FINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 43376-322
- What is NDC 43376-322?
- 43376-322 is the product NDC for Fintepla (fenfluramine), Fenfluramine 2.2 mg/mL solution, listed with the FDA by UCB, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fintepla (Fenfluramine).
- What is the active ingredient?
- Fenfluramine.
- Who is the labeler?
- UCB, Inc., NDC labeler code 43376. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fintepla?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.