Prescription drug · BLA
Palynziq (Pegvaliase-pqpz) NDC 68135-058
Pegvaliase 2.5 mg/.5mL · Injection, Solution · Subcutaneous · BioMarin Pharmaceutical Inc.
NDC codes
FDA NDC Directory| 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.NDC labeler code 68135
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761079
- Marketing start
- Listing expires
- 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.
- NDC on a medical claim
N468135005890followed by a unit qualifier and the quantityPackage 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
PALYNZIQ is indicated to reduce blood phenylalanine concentrations in adult and pediatric patients 12 years of age and older with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management. PALYNZIQ is a phenylalanine (Phe)-metabolizing enzyme indicated to reduce blood phenylalanine concentrations in adult and pediatric patients 12 years of age and older with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 68135-058
- What is NDC 68135-058?
- 68135-058 is the product NDC for Palynziq (pegvaliase-pqpz), Pegvaliase 2.5 mg/.5mL injection, solution, listed with the FDA by BioMarin Pharmaceutical Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Palynziq (Pegvaliase-pqpz).
- What is the active ingredient?
- Pegvaliase.
- Who is the labeler?
- BioMarin Pharmaceutical Inc., NDC labeler code 68135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Palynziq?
- 2 other product NDCs are listed under this name. See all Palynziq NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Palynziq products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Palynziqpegvaliase-pqpz | Pegvaliase 20 mg/mL | Injection, SolutionSubcutaneous | BioMarin Pharmaceutical Inc. | 68135-673 | 68135-0673-4068135-0673-45 |
| Palynziqpegvaliase-pqpz | Pegvaliase 10 mg/.5mL | Injection, SolutionSubcutaneous | BioMarin Pharmaceutical Inc. | 68135-756 | 68135-0756-20 |
Other NDCs under BLA 761079
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 |