FDA.reportPublic FDA data

cipaglucosidase alfa-atga 105 MG Injection [Pombiliti]

RxCUI
2667446
RxNorm name
cipaglucosidase alfa-atga 105 MG Injection [Pombiliti]
Display name
cipaglucosidase alfa-atga 105 MG Injection [Pombiliti]
Full name
cipaglucosidase alfa-atga 105 MG Injection [Pombiliti]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:23

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761204Pombiliticipaglucosidase alfa-atga351(a)Rx2026-06-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POMBILITI ATGACIPAGLUCOSIDASE ALFA-ATGAAMICUS THERAPEUTICS US, LLCd77aa596-910d-516b-e053-2995a90a08392026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2667446

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
d77aa596-910d-516b-e053-2995a90a0839cipaglucosidase alfa-atga 105 MG Injection [Pombiliti]SBD5These highlights do not include all the information needed to use POMBILITI ® safely and effectively. See full prescribing information for POMBILITI. POMBILITI (cipaglucosidase alfa-atga) for injection, for intravenous use Initial U.S. Approval: 202320241127
d77aa596-910d-516b-e053-2995a90a0839Pombiliti 105 MG InjectionSY5These highlights do not include all the information needed to use POMBILITI ® safely and effectively. See full prescribing information for POMBILITI. POMBILITI (cipaglucosidase alfa-atga) for injection, for intravenous use Initial U.S. Approval: 202320241127
d77aa596-910d-516b-e053-2995a90a0839POMBILITI 105 MG InjectionPSN5These highlights do not include all the information needed to use POMBILITI ® safely and effectively. See full prescribing information for POMBILITI. POMBILITI (cipaglucosidase alfa-atga) for injection, for intravenous use Initial U.S. Approval: 202320241127