Palynziq

UNIISPLATC A16AB19

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerBioMarin Pharmaceutical Inc.

CountryUS (United States)

ATC codeA16AB19

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6813567340
1 SYRINGE in 1 CARTON (68135-673-40) / 1 mL in 1 SYRINGE (68135-673-39)
ndc11
6813567345
10 SYRINGE in 1 CARTON (68135-673-45) / 1 mL in 1 SYRINGE (68135-673-39)

Annotations

UNII (FDA Substance ID)

N6UAH27EUV

PEGVALIASE

RxCUI 2046360

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "N6UAH27EUV",
    "rxcui": "2046360",
    "inchikey": null,
    "display_name": "PEGVALIASE",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "6dba844a-db02-44f8-8593-ce497ed9406c": {
      "match": "brand_token",
      "title": "PALYNZIQ (PEGVALIASE-PQPZ) INJECTION, SOLUTION [BIOMARIN PHARMACEUTICAL INC.]",
      "spl_version": "36",
      "published_date": "2026-03-09"
    }
  },
  "productid": "68135-673_b7b7caec-2808-4d88-ae34-1129a2cb1aef",
  "productndc": "68135-673",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PEGVALIASE",
  "proprietary_name": "Palynziq",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA761079",
  "marketing_category": "BLA",
  "nonproprietary_name": "pegvaliase-pqpz",
  "start_marketing_date": "20180524",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code A16AB19.

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