Palynziq (pegvaliase-pqpz) NDC 68135-058

NDC codes

FDA NDC Directory

Product NDC (as listed)68135-058Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68135-0058Add 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
68135-058-90	68135005890	1 SYRINGE in 1 CARTON (68135-058-90) / .5 mL in 1 SYRINGE (68135-058-89)Marketed from May 24, 2018

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): Palynziq
Generic name (nonproprietary): pegvaliase-pqpz
Active ingredients: Pegvaliase — 2.5 mg/.5mL
Dosage form: Injection, Solution
Route: Subcutaneous
Labeler: BioMarin Pharmaceutical Inc.
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761079
Marketing start: May 24, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Phenylalanine Ammonia-Lyase (Chemical structure)
Identifiers: Product ID 68135-058_b7b7caec-2808-4d88-ae34-1129a2cb1aefSPL ID b7b7caec-2808-4d88-ae34-1129a2cb1aefSPL set ID 6dba844a-db02-44f8-8593-ce497ed9406cRxCUI 2046365, 2046370, 2046374, 2046376, 2046379, 2046380UNII N6UAH27EUV
Pharmacologic class: Phenylalanine Metabolizing Enzyme

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.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N468135005890 followed by a unit qualifier and the quantity

Package 68135-0058-90. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under BLA 761079

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

FDA NDC Directory listings under BLA 761079
Product	Strength	Form · route	Labeler	Product NDC
Palynziqpegvaliase-pqpz	Pegvaliase 20 mg/mL	Injection, SolutionSubcutaneous	BioMarin Pharmaceutical Inc.	68135-673
Palynziqpegvaliase-pqpz	Pegvaliase 10 mg/.5mL	Injection, SolutionSubcutaneous	BioMarin Pharmaceutical Inc.	68135-756