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United States · US · US:71904-200_378efc18-b873-47fa-b558-5ea92904a165

POMBILITI

UNIISPLATC A16AB23

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAMICUS THERAPEUTICS US, LLC
CountryUS (United States)
ATC codeA16AB23
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7190420001
    1 VIAL, GLASS in 1 CARTON (71904-200-01) / 105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
  • ndc11
    7190420002
    10 VIAL, GLASS in 1 CARTON (71904-200-02) / 105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
  • ndc11
    7190420003
    25 VIAL, GLASS in 1 CARTON (71904-200-03) / 105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
4SED7F4BSG
CIPAGLUCOSIDASE ALFA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4SED7F4BSG",
    "rxcui": null,
    "inchikey": null,
    "display_name": "CIPAGLUCOSIDASE ALFA",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "d77aa596-910d-516b-e053-2995a90a0839": {
      "match": "brand_token",
      "title": "POMBILITI ATGA (CIPAGLUCOSIDASE ALFA-ATGA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMICUS THERAPEUTICS US, LLC]",
      "spl_version": "5",
      "published_date": "2024-12-09"
    }
  },
  "productid": "71904-200_378efc18-b873-47fa-b558-5ea92904a165",
  "productndc": "71904-200",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CIPAGLUCOSIDASE ALFA",
  "proprietary_name": "POMBILITI",
  "active_ingred_unit": "mg/1",
  "application_number": "BLA761204",
  "marketing_category": "BLA",
  "nonproprietary_name": "cipaglucosidase alfa-atga",
  "start_marketing_date": "20231011",
  "active_numerator_strength": "105"
}

Related drugs

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