OPFOLDA
- Product NDC
- 71904-300
- 11-digit product format
- 719040300
- Labeler code
- 71904
- Product ID
- 71904-300_82a91fa0-6c38-452c-a5d0-2c2f7355f540
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- miglustat
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- AMICUS THERAPEUTICS US, LLC
- Application
- NDA215211
- Marketing category
- NDA
- Marketing start
- 2023-10-11
- Substance
- MIGLUSTAT
- Active strength
- 65 mg/1
- Pharmacologic classes
- Enzyme Stabilizer [EPC], Enzyme Stabilizers [MoA], Glucosylceramide Synthase Inhibitor [EPC], Glucosylceramide Synthase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OPFOLDA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MIGLUSTAT | 65 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ADN3S497AZ |
| Rxcui | 2667426, 2667432 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71904-300-01 | OPFOLDA | 1 in 1 BOTTLE, PLASTIC | CAPSULE | 1 | | 5 |
| 71904-300-01 | OPFOLDA | 4 in 1 BOTTLE, PLASTIC | CAPSULE | 4 | | 5 |
| 71904-300-02 | OPFOLDA | 1 in 1 BOTTLE, PLASTIC | CAPSULE | 1 | | 5 |
| 71904-300-02 | OPFOLDA | 24 in 1 BOTTLE, PLASTIC | CAPSULE | 24 | | 5 |
| 71904-300-03 | OPFOLDA | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | | 5 |
| 71904-300-03 | OPFOLDA | 1 in 1 BOTTLE, PLASTIC | CAPSULE | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71904-300 | OPFOLDA (MIGLUSTAT) CAPSULE [AMICUS THERAPEUTICS US, LLC] | 5 | Current NDC, 6 package rows | 20241207_d7c38298-37db-5a80-e053-2995a90aee40.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71904-300-01 | 71904030001 | 4 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-01) / 1 CAPSULE in 1 BOTTLE, PLASTIC | 2023-10-11 | No | No | Historical |
| 71904-300-02 | 71904030002 | 24 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-02) / 1 CAPSULE in 1 BOTTLE, PLASTIC | 2023-10-11 | No | No | Historical |
| 71904-300-03 | 71904030003 | 100 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-03) / 1 CAPSULE in 1 BOTTLE, PLASTIC | 2023-10-11 | No | No | Historical |