TECELRA
- Product NDC
- 87262-160
- 11-digit product format
- 872620160
- Labeler code
- 87262
- Product ID
- 87262-160_5eaeb5c3-0100-4714-9bc3-917f0f7538f2
- Type
- CELLULAR THERAPY
- Nonproprietary name
- afamitresgene autoleucel
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAVENOUS
- Labeler
- USWM CT, LLC
- Application
- BLA125789
- Marketing category
- BLA
- Marketing start
- 2026-01-19
- Substance
- AFAMITRESGENE AUTOLEUCEL
- Active strength
- 10000000000 1/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TECELRA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AFAMITRESGENE AUTOLEUCEL | 10000000000 1/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CUY18BJ7BP |
| Rxcui | 2690269, 2690275 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 87262-160-02 | TECELRA | 1 in 1 BAG | INJECTION, SUSPENSION | 1 | | 1 |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 2690269 | afamitresgene autoleucel 10,000,000,000 CELLS in 250 ML Injection | PSN | 2ddd66e1-8036-4a4e-babe-4d673e660bf5 | 1 |
| 2690275 | Tecelra 10,000,000,000 CELLS in 250 ML Injection | PSN | 2ddd66e1-8036-4a4e-babe-4d673e660bf5 | 1 |
| 2690275 | 250 ML afamitresgene autoleucel 40000000 CELLS/ML Injection [Tecelra] | SBD | 2ddd66e1-8036-4a4e-babe-4d673e660bf5 | 1 |
| 2690269 | 250 ML afamitresgene autoleucel 40000000 CELLS/ML Injection | SCD | 2ddd66e1-8036-4a4e-babe-4d673e660bf5 | 1 |
| 2690269 | afamitresgene autoleucel 10,000,000,000 CELLS per 250 ML Injection | SY | 2ddd66e1-8036-4a4e-babe-4d673e660bf5 | 1 |
| 2690275 | Tecelra 10,000,000,000 CELLS per 250 ML Injection | SY | 2ddd66e1-8036-4a4e-babe-4d673e660bf5 | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 87262-160-02 | 87262016002 | 1 INJECTION, SUSPENSION in 1 BAG (87262-160-02) | 2026-01-19 | No | No | Current |