NDC codes

FDA NDC Directory
Product NDC (as listed)43376-322Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43376-0322Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
43376-322-30433760322301 BOTTLE, PLASTIC in 1 CARTON (43376-322-30) / 30 mL in 1 BOTTLE, PLASTICMarketed from Jul 15, 2020
43376-322-36433760322361 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

N443376032230 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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