Prescription drug · NDA

Sephience (sepiapterin) NDC 60468-007

Sepiapterin 250 mg/1 · Powder · Oral · allphamed Pharbil Arzneimittel GmbH

NDC codes

FDA NDC Directory
Product NDC (as listed)60468-007Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60468-0007Add 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
60468-007-036046800070330 PACKET in 1 CARTON (60468-007-03) / 1 POWDER in 1 PACKET (60468-007-01)Marketed from Jul 28, 2025

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)
Sephience
Generic name (nonproprietary)
sepiapterin
Active ingredients
Sepiapterin — 250 mg/1
Dosage form
Powder
Route
Oral
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 219666
Marketing start
Listing expires
Identifiers
Product ID 60468-007_4031b751-a798-3024-e063-6294a90ac2b4SPL ID 4031b751-a798-3024-e063-6294a90ac2b4SPL set ID 9fabfee2-9488-4d03-b203-8fa50f9a7f55RxCUI 2723061, 2723067, 2723069, 2723071UNII CJQ26KO7HPUPC 0352856201033

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

N460468000703 followed by a unit qualifier and the quantity

Package 60468-0007-03. 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 .

Indications (excerpt from the label)

SEPHIENCE is indicated for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive phenylketonuria (PKU). SEPHIENCE is to be used in conjunction with a phenylalanine (Phe)-restricted diet. SEPHIENCE is a phenylalanine hydroxylase (PAH) activator indicated for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive phenylketonuria (PKU). SEPHIENCE is to be used in conjunction with a phenylalanine (Phe)- restricted diet. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 219666

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 219666
ProductStrengthForm · routeLabelerProduct NDC
SephiencesepiapterinSepiapterin 250 mg/1PowderOralPTC Therapeutics Inc.52856-201
SephiencesepiapterinSepiapterin 1000 mg/1PowderOralPTC Therapeutics Inc.52856-301
SephiencesepiapterinSepiapterin 1000 mg/1PowderOralallphamed Pharbil Arzneimittel GmbH60468-006

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Sephience (sepiapterin) NDC 60468-007 | Med-Code