What is NDC 71394-415?

71394-415 is the product NDC for Luxturna (voretigene neparvovec-rzyl) kit, listed with the FDA by Spark Therapeutics, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Spark Therapeutics, Inc., NDC labeler code 71394. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Luxturna?

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.

Luxturna NDC 71394-415 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71394-415Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71394-0415Add 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 NDC	11-digit (billing)	Package	Copy
71394-415-01	71394041501	1 KIT in 1 CARTON (71394-415-01) * 1 INJECTION, SUSPENSION in 1 VIAL, PLASTIC (71394-065-01) * 1 INJECTION, SOLUTION in 1 VIAL, PLASTIC (71394-716-01)Marketed from Dec 19, 2017

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): Luxturna
Generic name (nonproprietary): voretigene neparvovec-rzyl
Dosage form: Kit
Labeler: Spark Therapeutics, Inc.NDC labeler code 71394
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 125610
Marketing start: Dec 19, 2017
Listing expires: Dec 31, 2027
Identifiers: Product ID 71394-415_173eb100-b8ab-4255-bad7-466d01195c6dSPL ID 173eb100-b8ab-4255-bad7-466d01195c6dSPL set ID 08313a24-e7ce-457a-bb3f-161bc45517eeRxCUI 1995884, 1995886

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N471394041501 followed by a unit qualifier and the quantity

Package 71394-0415-01. 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 May 1, 2022.

Indications (excerpt from the label)

LUXTURNA (voretigene neparvovec-rzyl) is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. Patients must have viable retinal cells as determined by the treating physician(s). LUXTURNA is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. Patients must have viable retinal cells as determined by the treating physician(s). ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71394-415

What is NDC 71394-415?: 71394-415 is the product NDC for Luxturna (voretigene neparvovec-rzyl) kit, listed with the FDA by Spark Therapeutics, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Luxturna (Voretigene neparvovec-rzyl).
Who is the labeler?: Spark Therapeutics, Inc., NDC labeler code 71394. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Luxturna?: 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.

Luxturna (Voretigene neparvovec-rzyl) NDC 71394-415