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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
- ndc1171904200011 VIAL, GLASS in 1 CARTON (71904-200-01) / 105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
- ndc11719042000210 VIAL, GLASS in 1 CARTON (71904-200-02) / 105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
- ndc11719042000325 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
Other records sharing ATC code A16AB23.
- FIPombilitiAmicus Therapeutics Europe Limited
- ISPombilitiAmicus Therapeutics Europe Limited*
- NOPombilitiAmicus Therapeutics Europe Limited
- 🇨🇭Pombiliti
- PLPombilitiAmicus Therapeutics Europe Limited
- 🇨🇭PombilitiAmicus Therapeutics Switzerland GmbH
- DKPombilitiAmicus Therapeutics Europe Ltd
- CZPOMBILITIAmicus Therapeutics Europe Limited, Dublin
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