MODEYSO
- Product NDC
- 68727-250
- 11-digit product format
- 687270250
- Labeler code
- 68727
- Product ID
- 68727-250_9d57dcc7-fa17-4ecf-ada1-3a4b1cf92032
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dordaviprone
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Jazz Pharmaceuticals, Inc.
- Application
- NDA219876
- Marketing category
- NDA
- Marketing start
- 2025-08-06
- Substance
- DORDAVIPRONE
- Active strength
- 125 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MODEYSO
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DORDAVIPRONE | 125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9U35A31JAI |
| Rxcui | 2721199, 2721205 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68727-250-01 | MODEYSO | 1 in 1 CARTON | CAPSULE | 1 | | 2 |
| 68727-250-01 | MODEYSO | 10 in 1 BOTTLE | CAPSULE | 10 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68727-250-01 | 68727025001 | 1 BOTTLE in 1 CARTON (68727-250-01) / 10 CAPSULE in 1 BOTTLE | 1 bottle | 2025-08-06 | No | No | Current |