Voydeya
- Product NDC
- 25682-046
- 11-digit product format
- 256820046
- Labeler code
- 25682
- Product ID
- 25682-046_cd0113b0-d5d6-4b03-9f6f-4d80bdcb71fe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Danicopan
- Dosage form
- KIT
- Labeler
- Alexion Pharmaceuticals Inc.
- Application
- NDA218037
- Marketing category
- NDA
- Marketing start
- 2024-03-29
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Voydeya
- Listing expiration
- 2027-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JM8C1SFX0U |
| Rxcui | 2678957, 2678963, 2678965, 2678967, 2678972, 2678973, 2678974, 2678975 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25682-040-90 | Voydeya | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 50 mg | 5 |
| 25682-043-90 | Voydeya | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 100 mg | 5 |
| 25682-046-92 | Voydeya | 1 in 1 CARTON | KIT | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25682-046 | VOYDEYA (DANICOPAN) TABLET, FILM COATED VOYDEYA (DANICOPAN) KIT [ALEXION PHARMACEUTICALS INC.] | 3 | Current NDC, 3 package rows | 20241210_ab8d1cbd-a28b-4d49-82ab-5c7460719ac7.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 2678973 | {180 (danicopan 100 MG Oral Tablet [Voydeya]) } Pack [Voydeya 200 MG Dose Bottle] | BPCK | ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 | 5 |
| 2678975 | {90 (danicopan 100 MG Oral Tablet [Voydeya]) / 90 (danicopan 50 MG Oral Tablet [Voydeya]) } Pack [Voydeya 150 MG Dose Bottle] | BPCK | ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 | 5 |
| 2678972 | {180 (danicopan 100 MG Oral Tablet) } Pack | GPCK | ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 | 5 |
| 2678974 | {90 (danicopan 100 MG Oral Tablet) / 90 (danicopan 50 MG Oral Tablet) } Pack | GPCK | ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 | 5 |
| 2678965 | danicopan 100 MG Oral Tablet | PSN | ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 | 5 |
| 2678974 | danicopan 150 MG Dose, 2 Bottle Kit | PSN | ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 | 5 |
| 2678972 | danicopan 200 MG Dose, 2 Bottle Kit | PSN | ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 | 5 |
| 2678957 | danicopan 50 MG Oral Tablet | PSN | ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 | 5 |
| 2678967 | Voydeya 100 MG Oral Tablet | PSN | ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 | 5 |
| 2678975 | Voydeya 150 MG Dose, 2 Bottle Kit | PSN | ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 | 5 |
| 2678973 | Voydeya 200 MG Dose, 2 Bottle Kit | PSN | ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 | 5 |
| 2678963 | Voydeya 50 MG Oral Tablet | PSN | ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 | 5 |
| 2678967 | danicopan 100 MG Oral Tablet [Voydeya] | SBD | ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 | 5 |
| 2678963 | danicopan 50 MG Oral Tablet [Voydeya] | SBD | ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 | 5 |
| 2678965 | danicopan 100 MG Oral Tablet | SCD | ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 | 5 |
| 2678957 | danicopan 50 MG Oral Tablet | SCD | ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 | 5 |
| 2678974 | danicopan 150 MG Dose, 2 Bottle Kit | SY | ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 | 5 |
| 2678972 | danicopan 200 MG Dose, 2 Bottle Kit | SY | ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 | 5 |
| 2678967 | Voydeya 100 MG Oral Tablet | SY | ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 | 5 |
| 2678975 | Voydeya 150 MG Dose, 2 Bottle Kit | SY | ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 | 5 |
| 2678973 | Voydeya 200 MG Dose, 2 Bottle Kit | SY | ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 | 5 |
| 2678963 | Voydeya 50 MG Oral Tablet | SY | ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 | 5 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 25682-040-90 | 25682004090 | 90 in 1 BOTTLE | | | | | Historical |
| 25682-043-90 | 25682004390 | 90 in 1 BOTTLE | | | | | Historical |
| 25682-046-92 | 25682004692 | 1 KIT in 1 CARTON (25682-046-92) * 90 TABLET, FILM COATED in 1 BOTTLE (25682-040-90) * 90 TABLET, FILM COATED in 1 BOTTLE (25682-043-90) | 1 kit | 2024-03-29 | No | No | Current |