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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIPAGLUCOSIDASE ALFA105 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4SED7F4BSG
Rxcui2667440, 2667446

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

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, GLASS2023-10-11NoNoHistorical
71904-200-027190402000210 VIAL, GLASS in 1 CARTON (71904-200-02) / 105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS2023-10-11NoNoHistorical
71904-200-037190402000325 VIAL, GLASS in 1 CARTON (71904-200-03) / 105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS2023-10-11NoNoHistorical