NDC 68135-058

Palynziq

Pegvaliase-pqpz

Palynziq is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Biomarin Pharmaceutical Inc.. The primary component is Pegvaliase.

• Product ID: 68135-058_13686fc1-3709-4731-9500-dd9d53a48d12
• NDC: 68135-058
• Product Type: Human Prescription Drug
• Proprietary Name: Palynziq
• Generic Name: Pegvaliase-pqpz
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2018-05-24
• Marketing Category: BLA / BLA
• Application Number: BLA761079
• Labeler Name: BioMarin Pharmaceutical Inc.
• Substance Name: PEGVALIASE
• Active Ingredient Strength: 3 mg/.5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 68135-058-90

1 SYRINGE in 1 CARTON (68135-058-90) > .5 mL in 1 SYRINGE (68135-058-89)

• Marketing Start Date: 2018-05-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68135-058-89 [68135005889]

Palynziq INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761079
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-05-24

NDC 68135-058-90 [68135005890]

Palynziq INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761079
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-05-24

Drug Details

Active Ingredients

Ingredient	Strength
PEGVALIASE	2.5 mg/.5mL

OpenFDA Data

• SPL SET ID: 6dba844a-db02-44f8-8593-ce497ed9406c
• Manufacturer:
  • BioMarin Pharmaceutical Inc.
• UNII:
  • N6UAH27EUV
• RxNorm Concept Unique ID - RxCUI:
  • 2046379
  • 2046370
  • 2046374
  • 2046376
  • 2046365
  • 2046380

NDC Crossover Matching brand name "Palynziq" or generic name "Pegvaliase-pqpz"

NDC	Brand Name	Generic Name
68135-058	Palynziq	pegvaliase-pqpz
68135-673	Palynziq	pegvaliase-pqpz
68135-756	Palynziq	pegvaliase-pqpz