palynziq

Generic: pegvaliase-pqpz

Labeler: biomarin pharmaceutical inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name palynziq
Generic Name pegvaliase-pqpz
Labeler biomarin pharmaceutical inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

pegvaliase 2.5 mg/.5mL

Manufacturer
BioMarin Pharmaceutical Inc.

Identifiers & Regulatory

Product NDC 68135-058
Product ID 68135-058_b7b7caec-2808-4d88-ae34-1129a2cb1aef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761079
Listing Expiration 2027-12-31
Marketing Start 2018-05-24

Pharmacologic Class

Established (EPC)
phenylalanine metabolizing enzyme [epc]
Chemical Structure
phenylalanine ammonia-lyase [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68135058
Hyphenated Format 68135-058

Supplemental Identifiers

RxCUI
2046365 2046370 2046374 2046376 2046379 2046380
UNII
N6UAH27EUV
NUI
N0000193858 M0016545

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name palynziq (source: ndc)
Generic Name pegvaliase-pqpz (source: ndc)
Application Number BLA761079 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/.5mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (68135-058-90) / .5 mL in 1 SYRINGE (68135-058-89)
source: ndc

Packages (1)

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

Ingredients (1)

pegvaliase (2.5 mg/.5mL)

Linked Drug Pages (1)

Palynziq ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "b7b7caec-2808-4d88-ae34-1129a2cb1aef", "openfda": {"nui": ["N0000193858", "M0016545"], "unii": ["N6UAH27EUV"], "rxcui": ["2046365", "2046370", "2046374", "2046376", "2046379", "2046380"], "spl_set_id": ["6dba844a-db02-44f8-8593-ce497ed9406c"], "pharm_class_cs": ["Phenylalanine Ammonia-Lyase [CS]"], "pharm_class_epc": ["Phenylalanine Metabolizing Enzyme [EPC]"], "manufacturer_name": ["BioMarin Pharmaceutical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (68135-058-90)  / .5 mL in 1 SYRINGE (68135-058-89)", "package_ndc": "68135-058-90", "marketing_start_date": "20180524"}], "brand_name": "Palynziq", "product_id": "68135-058_b7b7caec-2808-4d88-ae34-1129a2cb1aef", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Phenylalanine Ammonia-Lyase [CS]", "Phenylalanine Metabolizing Enzyme [EPC]"], "product_ndc": "68135-058", "generic_name": "pegvaliase-pqpz", "labeler_name": "BioMarin Pharmaceutical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Palynziq", "active_ingredients": [{"name": "PEGVALIASE", "strength": "2.5 mg/.5mL"}], "application_number": "BLA761079", "marketing_category": "BLA", "marketing_start_date": "20180524", "listing_expiration_date": "20271231"}