ENCELTO
- Product NDC
- 82958-501
- 11-digit product format
- 829580501
- Labeler code
- 82958
- Product ID
- 82958-501_bf748572-feba-4465-99e0-234e04a63cfc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- revakinagene taroretcel-lwey
- Dosage form
- IMPLANT
- Route
- INTRAVITREAL
- Labeler
- Neurotech Pharmaceuticals, Inc.
- Application
- BLA125798
- Marketing category
- BLA
- Marketing start
- 2025-03-12
- Substance
- REVAKINAGENE TARORETCEL
- Active strength
- 440000 [arb'U]/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ENCELTO
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| REVAKINAGENE TARORETCEL | 440000 [arb'U]/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q7V7NYG6GM |
| Rxcui | 2708837, 2708843 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82958-501-01 | ENCELTO | 1 in 1 CAPSULE | IMPLANT | 1 | | 2 |
| 82958-501-01 | ENCELTO | 1 in 1 CONTAINER | IMPLANT | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82958-501 | ENCELTO (REVAKINAGENE TARORETCEL-LWEY) IMPLANT [NEUROTECH PHARMACEUTICALS, INC.] | 2 | Current NDC, 2 package rows | 20250326_1ae9482a-b478-4e21-9166-b5fd52d3ef9c.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 2708843 | ENCELTO 200,000 to 440,000 CELLS Intravitreal Implant | PSN | 1ae9482a-b478-4e21-9166-b5fd52d3ef9c | 2 |
| 2708837 | revakinagene taroretcel-lwey 200,000 to 440,000 CELLS Intravitreal Implant | PSN | 1ae9482a-b478-4e21-9166-b5fd52d3ef9c | 2 |
| 2708843 | revakinagene taroretcel-lwey 440000 CELLS Drug Implant [Encelto] | SBD | 1ae9482a-b478-4e21-9166-b5fd52d3ef9c | 2 |
| 2708837 | revakinagene taroretcel-lwey 440000 CELLS Drug Implant | SCD | 1ae9482a-b478-4e21-9166-b5fd52d3ef9c | 2 |
| 2708843 | Encelto 200,000 to 440,000 CELLS Intravitreal Implant | SY | 1ae9482a-b478-4e21-9166-b5fd52d3ef9c | 2 |
| 2708837 | revakinagene taroretcel-lwey 200,000 to 440,000 CELLS Intravitreal Implant | SY | 1ae9482a-b478-4e21-9166-b5fd52d3ef9c | 2 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82958-501-01 | 82958050101 | 1 CAPSULE in 1 CONTAINER (82958-501-01) / 1 IMPLANT in 1 CAPSULE | 1 capsule | 2025-03-12 | No | No | Historical |