TECELRA
- Product NDC
- 83205-0001
- 11-digit product format
- 832050001
- Labeler code
- 83205
- Product ID
- 83205-0001_28fa3284-38e4-4fdf-8991-2b52fe3f19fc
- Type
- CELLULAR THERAPY
- Nonproprietary name
- afamitresgene autoleucel
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAVENOUS
- Labeler
- USWM, LLC
- Application
- BLA125789
- Marketing category
- BLA
- Marketing start
- 2024-08-02
- 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 |
|---|
| 83205-0001-2 | TECELRA | 1 in 1 BAG | INJECTION, SUSPENSION | 1 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83205-0001 | TECELRA (AFAMITRESGENE AUTOLEUCEL) INJECTION, SUSPENSION [ADAPTIMMUNE LLC] | 1 | Current NDC, 1 package rows | 20240809_ab24631f-3364-46e1-8074-7244863bcbab.zip |
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 | ab24631f-3364-46e1-8074-7244863bcbab | 13 |
| 2690275 | Tecelra 10,000,000,000 CELLS in 250 ML Injection | PSN | ab24631f-3364-46e1-8074-7244863bcbab | 13 |
| 2690275 | 250 ML afamitresgene autoleucel 40000000 CELLS/ML Injection [Tecelra] | SBD | ab24631f-3364-46e1-8074-7244863bcbab | 13 |
| 2690269 | 250 ML afamitresgene autoleucel 40000000 CELLS/ML Injection | SCD | ab24631f-3364-46e1-8074-7244863bcbab | 13 |
| 2690269 | afamitresgene autoleucel 10,000,000,000 CELLS per 250 ML Injection | SY | ab24631f-3364-46e1-8074-7244863bcbab | 13 |
| 2690275 | Tecelra 10,000,000,000 CELLS per 250 ML Injection | SY | ab24631f-3364-46e1-8074-7244863bcbab | 13 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 83205-0001-2 | 83205000102 | 1 INJECTION, SUSPENSION in 1 BAG (83205-0001-2) | 2024-08-02 | No | No | Current |