KEBILIDI
- Product NDC
- 52856-601
- 11-digit product format
- 528560601
- Labeler code
- 52856
- Product ID
- 52856-601_82f12b65-d2a0-450a-9f11-49ce8aad2e27
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- eladocagene exuparvovec-tneq
- Dosage form
- SUSPENSION
- Route
- INTRACEREBRAL
- Labeler
- PTC Therapeutics, Inc.
- Application
- BLA125722
- Marketing category
- BLA
- Marketing start
- 2024-11-13
- Substance
- ELADOCAGENE EXUPARVOVEC
- Active strength
- 560000000000 {GC}/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- KEBILIDI
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ELADOCAGENE EXUPARVOVEC | 560000000000 {GC}/mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52856-601-01 | KEBILIDI | 1 in 1 CARTON | SUSPENSION | 1 | | 3 |
| 52856-601-11 | KEBILIDI | 0.5 mL in 1 VIAL, GLASS | SUSPENSION | 0.5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52856-601 | KEBILIDI (ELADOCAGENE EXUPARVOVEC-TNEQ) SUSPENSION [PTC THERAPEUTICS, INC.] | 2 | Current NDC, 2 package rows | 20241204_9d6a6401-c6b5-4f29-af11-67707d249482.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 2698771 | eladocagene exuparvovec-tneq 560,000,000,000 VECTOR-GENOMES in 0.5 ML Injection | PSN | 9d6a6401-c6b5-4f29-af11-67707d249482 | 3 |
| 2698778 | Kebilidi 560,000,000,000 VECTOR-GENOMES in 0.5 ML Injection | PSN | 9d6a6401-c6b5-4f29-af11-67707d249482 | 3 |
| 2698778 | 0.5 ML eladocagene exuparvovec-tneq 560000000000 VECTOR-GENOMES/ML Injection [Kebilidi] | SBD | 9d6a6401-c6b5-4f29-af11-67707d249482 | 3 |
| 2698771 | 0.5 ML eladocagene exuparvovec-tneq 560000000000 VECTOR-GENOMES/ML Injection | SCD | 9d6a6401-c6b5-4f29-af11-67707d249482 | 3 |
| 2698778 | 0.5 ML Kebilidi 560000000000 VECTOR-GENOMES/ML Injection | SY | 9d6a6401-c6b5-4f29-af11-67707d249482 | 3 |
| 2698771 | eladocagene exuparvovec-tneq 560,000,000,000 VECTOR-GENOMES per 0.5 ML Injection | SY | 9d6a6401-c6b5-4f29-af11-67707d249482 | 3 |
| 2698778 | Kebilidi 560,000,000,000 VECTOR-GENOMES per 0.5 ML Injection | SY | 9d6a6401-c6b5-4f29-af11-67707d249482 | 3 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 52856-601-01 | 52856060101 | 1 VIAL, GLASS in 1 CARTON (52856-601-01) / .5 mL in 1 VIAL, GLASS (52856-601-11) | | 2024-11-13 | No | No | Current |
| 52856-601-11 | 52856060111 | 0.5 mL in 1 VIAL, GLASS | 0.5 ml | | | | Historical |