DailyMed label
Galafold
DailyMed label · Amicus Therapeutics US, LLC · version 18
Key facts
| Product | Galafold |
|---|---|
| Labeler | Amicus Therapeutics US, LLC |
| Document type | HUMAN PRESCRIPTION DRUG LABEL |
| Active ingredients | MIGALASTAT HYDROCHLORIDE |
| Active ingredient UNIIs | CLY7M0XD20 |
| Application number | 208623 |
| Route | ORAL |
| NDC package codes | 71904-100-01 |
| Effective date | Aug 28, 2025 |
| Set ID | 66dbd928-0f1c-48b1-a832-54e4abd9f1db |
At a glance
- 1–9 NDC package codes
- 1–9 Active ingredients
- None Manufacturing establishments listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About DailyMed drug labels
DailyMed publishes the structured product labeling (SPL) that companies submit to the FDA, including package NDCs, ingredients and the establishments that make each product.
Source: U.S. National Library of Medicine (NLM), DailyMed · Source date: