Galafold
- Product NDC
- 71904-100
- 11-digit product format
- 719040100
- Labeler code
- 71904
- Product ID
- 71904-100_2da6bbb5-63ae-4405-a1ad-25429b9f7139
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- migalastat hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amicus Therapeutics US, LLC
- Application
- NDA208623
- Marketing category
- NDA
- Marketing start
- 2018-08-10
- Substance
- MIGALASTAT HYDROCHLORIDE
- Active strength
- 123 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Galafold
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MIGALASTAT HYDROCHLORIDE | 123 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CLY7M0XD20 |
| Rxcui | 2054257, 2054263, 2054266, 2054275 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71904-100-01 | Galafold | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 18 |
| 71904-100-01 | Galafold | 14 in 1 CARTON | CAPSULE | 14 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71904-100 | GALAFOLD (MIGALASTAT HYDROCHLORIDE) CAPSULE [AMICUS THERAPEUTICS US, LLC] | 17 | Current NDC, Legacy NDC, 2 package rows | 20250406_66dbd928-0f1c-48b1-a832-54e4abd9f1db.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71904-100-01 | 71904010001 | 14 BLISTER PACK in 1 CARTON (71904-100-01) / 1 CAPSULE in 1 BLISTER PACK | 14 blister pack | 2018-08-10 | 0000-00-00 | No | No | Current |