FDA.reportPublic FDA data

POMBILITI

Product NDC
71904-200
11-digit product format
719040200
Labeler code
71904
Product ID
71904-200_378efc18-b873-47fa-b558-5ea92904a165
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cipaglucosidase alfa-atga
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
AMICUS THERAPEUTICS US, LLC
Application
BLA761204
Marketing category
BLA
Marketing start
2023-10-11
Substance
CIPAGLUCOSIDASE ALFA
Active strength
105 mg/1
Pharmacologic classes
Hydrolytic Lysosomal Glycogen-specific Enzyme [EPC], alpha-Glucosidases [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
POMBILITI
Brand name suffix
ATGA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIPAGLUCOSIDASE ALFA105 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4SED7F4BSGInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2667440Internal RxNorm lookup
2667446Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d77aa596-910d-516b-e053-2995a90a0839Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
320ce659-6cd3-424c-a0f7-8bc0215e39adProduct name120250625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71904-200-01POMBILITIATGA105 in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,1055
71904-200-01POMBILITIATGA1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,15
71904-200-02POMBILITIATGA105 in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,1055
71904-200-02POMBILITIATGA10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,105
71904-200-03POMBILITIATGA25 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,255
71904-200-03POMBILITIATGA105 in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,1055

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71904-200POMBILITI ATGA (CIPAGLUCOSIDASE ALFA-ATGA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMICUS THERAPEUTICS US, LLC]5Current NDC, 6 package rows20241207_d77aa596-910d-516b-e053-2995a90a0839.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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-e053-2995a90a08392026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761204
ndc (product): 71904-200

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761204Pombiliticipaglucosidase alfa-atga351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2667440cipaglucosidase alfa-atga 105 MG InjectionPSNd77aa596-910d-516b-e053-2995a90a08395
2667446POMBILITI 105 MG InjectionPSNd77aa596-910d-516b-e053-2995a90a08395
2667446cipaglucosidase alfa-atga 105 MG Injection [Pombiliti]SBDd77aa596-910d-516b-e053-2995a90a08395
2667440cipaglucosidase alfa-atga 105 MG InjectionSCDd77aa596-910d-516b-e053-2995a90a08395
2667446Pombiliti 105 MG InjectionSYd77aa596-910d-516b-e053-2995a90a08395

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71904-200-01719040200011 VIAL, GLASS in 1 CARTON (71904-200-01) / 105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS2023-10-11NoNoCurrent
71904-200-027190402000210 VIAL, GLASS in 1 CARTON (71904-200-02) / 105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS2023-10-11NoNoCurrent
71904-200-037190402000325 VIAL, GLASS in 1 CARTON (71904-200-03) / 105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS2023-10-11NoNoCurrent