galafold

Generic: migalastat hydrochloride

Labeler: amicus therapeutics us, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name galafold
Generic Name migalastat hydrochloride
Labeler amicus therapeutics us, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

migalastat hydrochloride 123 mg/1

Manufacturer
Amicus Therapeutics US, LLC

Identifiers & Regulatory

Product NDC 71904-100
Product ID 71904-100_2da6bbb5-63ae-4405-a1ad-25429b9f7139
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208623
Listing Expiration 2026-12-31
Marketing Start 2018-08-10

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71904100
Hyphenated Format 71904-100

Supplemental Identifiers

RxCUI
2054257 2054263 2054266 2054275
UPC
0371904100012
UNII
CLY7M0XD20

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 galafold (source: ndc)
Generic Name migalastat hydrochloride (source: ndc)
Application Number NDA208623 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 123 mg/1
source: ndc
Packaging
  • 14 BLISTER PACK in 1 CARTON (71904-100-01) / 1 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

71904-100-01 14 BLISTER PACK in 1 CARTON (71904-100-01) / 1 CAPSULE in 1 BLISTER PACK

Ingredients (1)

migalastat hydrochloride (123 mg/1)

Linked Drug Pages (1)

Galafold ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2da6bbb5-63ae-4405-a1ad-25429b9f7139", "openfda": {"upc": ["0371904100012"], "unii": ["CLY7M0XD20"], "rxcui": ["2054257", "2054263", "2054266", "2054275"], "spl_set_id": ["66dbd928-0f1c-48b1-a832-54e4abd9f1db"], "manufacturer_name": ["Amicus Therapeutics US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 BLISTER PACK in 1 CARTON (71904-100-01)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "71904-100-01", "marketing_start_date": "20180810"}], "brand_name": "Galafold", "product_id": "71904-100_2da6bbb5-63ae-4405-a1ad-25429b9f7139", "dosage_form": "CAPSULE", "product_ndc": "71904-100", "generic_name": "migalastat hydrochloride", "labeler_name": "Amicus Therapeutics US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Galafold", "active_ingredients": [{"name": "MIGALASTAT HYDROCHLORIDE", "strength": "123 mg/1"}], "application_number": "NDA208623", "marketing_category": "NDA", "marketing_start_date": "20180810", "listing_expiration_date": "20261231"}