NDC 71904-100

Galafold

Migalastat Hydrochloride

Galafold is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Amicus Therapeutics U.s., Inc.. The primary component is Migalastat Hydrochloride.

• Product ID: 71904-100_4fd6ae5f-f245-435d-a0f5-bb6874e585f7
• NDC: 71904-100
• Product Type: Human Prescription Drug
• Proprietary Name: Galafold
• Generic Name: Migalastat Hydrochloride
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2018-08-10
• Marketing Category: NDA / NDA
• Application Number: NDA208623
• Labeler Name: Amicus Therapeutics U.S., Inc.
• Substance Name: MIGALASTAT HYDROCHLORIDE
• Active Ingredient Strength: 123 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 71904-100-01

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

• Marketing Start Date: 2018-08-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71904-100-01 [71904010001]

Galafold CAPSULE

• Marketing Category: NDA
• Application Number: NDA208623
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-08-10

Drug Details

Active Ingredients

Ingredient	Strength
MIGALASTAT HYDROCHLORIDE	123 mg/1

OpenFDA Data

• SPL SET ID: 66dbd928-0f1c-48b1-a832-54e4abd9f1db
• Manufacturer:
  • Amicus Therapeutics U.S., Inc.
• UNII:
  • CLY7M0XD20
• RxNorm Concept Unique ID - RxCUI:
  • 2054257
  • 2054263
  • 2054275
  • 2054266
• UPC Code:
  • 0371904100012