pombiliti atga (71904-200)

Drug Facts

Product Profile

Brand Name pombiliti atga

Generic Name cipaglucosidase alfa-atga

Labeler amicus therapeutics us, llc

Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Routes

INTRAVENOUS

Active Ingredients

cipaglucosidase alfa 105 mg/1

Manufacturer

AMICUS THERAPEUTICS US, LLC

Identifiers & Regulatory

Product NDC 71904-200

Product ID 71904-200_378efc18-b873-47fa-b558-5ea92904a165

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category BLA

Application Number BLA761204

Listing Expiration 2026-12-31

Marketing Start 2023-10-11

Pharmacologic Class

Classes

hydrolytic lysosomal glycogen-specific enzyme [epc] alpha-glucosidases [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71904200

Hyphenated Format 71904-200

Supplemental Identifiers

RxCUI

2667440 2667446

UPC

0371904200033 0371904200019

UNII

4SED7F4BSG

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pombiliti atga (source: ndc)

Generic Name cipaglucosidase alfa-atga (source: ndc)

Application Number BLA761204 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

105 mg/1

source: ndc

Packaging

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

source: ndc

Packages (3)

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

Ingredients (1)

cipaglucosidase alfa (105 mg/1)

Linked Drug Pages (1)

POMBILITI ATGA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAVENOUS"], "spl_id": "378efc18-b873-47fa-b558-5ea92904a165", "openfda": {"upc": ["0371904200033", "0371904200019"], "unii": ["4SED7F4BSG"], "rxcui": ["2667440", "2667446"], "spl_set_id": ["d77aa596-910d-516b-e053-2995a90a0839"], "manufacturer_name": ["AMICUS THERAPEUTICS US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (71904-200-01)  / 105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS", "package_ndc": "71904-200-01", "marketing_start_date": "20231011"}, {"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (71904-200-02)  / 105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS", "package_ndc": "71904-200-02", "marketing_start_date": "20231011"}, {"sample": false, "description": "25 VIAL, GLASS in 1 CARTON (71904-200-03)  / 105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS", "package_ndc": "71904-200-03", "marketing_start_date": "20231011"}], "brand_name": "POMBILITI ATGA", "product_id": "71904-200_378efc18-b873-47fa-b558-5ea92904a165", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Hydrolytic Lysosomal Glycogen-specific Enzyme [EPC]", "alpha-Glucosidases [CS]"], "product_ndc": "71904-200", "generic_name": "cipaglucosidase alfa-atga", "labeler_name": "AMICUS THERAPEUTICS US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "POMBILITI", "brand_name_suffix": "ATGA", "active_ingredients": [{"name": "CIPAGLUCOSIDASE ALFA", "strength": "105 mg/1"}], "application_number": "BLA761204", "marketing_category": "BLA", "marketing_start_date": "20231011", "listing_expiration_date": "20261231"}