ITVISMA
- Product NDC
- 71894-200
- 11-digit product format
- 718940200
- Labeler code
- 71894
- Product ID
- 71894-200_ab2e1c6c-4f95-4243-9296-1734e0a30591
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- onasemnogene abeparvovec-brve
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRATHECAL
- Labeler
- Novartis Gene Therapies, Inc.
- Application
- BLA125856
- Marketing category
- BLA
- Marketing start
- 2025-11-24
- Substance
- ONASEMNOGENE ABEPARVOVEC
- Active strength
- 40000000000000 [arb'U]/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ITVISMA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ONASEMNOGENE ABEPARVOVEC | 40000000000000 [arb'U]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MLU3LU3EVV |
| Rxcui | 2727307, 2727314 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71894-200-01 | ITVISMA | 3 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SUSPENSION | 3 | | 1 |
| 71894-200-02 | ITVISMA | 1 in 1 CARTON | INJECTION, SUSPENSION | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71894-200-01 | 71894020001 | 3 mL in 1 VIAL, SINGLE-DOSE | 3 ml | | | | Historical |
| 71894-200-02 | 71894020002 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71894-200-02) / 3 mL in 1 VIAL, SINGLE-DOSE (71894-200-01) | | 2025-11-24 | No | No | Current |