TYRUKO
- Product NDC
- 61314-543
- 11-digit product format
- 613140543
- Labeler code
- 61314
- Product ID
- 61314-543_29c4086f-ca52-4f83-9119-bada7ec65482
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- natalizumab-sztn
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Sandoz Inc
- Application
- BLA761322
- Marketing category
- BLA
- Marketing start
- 2025-11-17
- Substance
- NATALIZUMAB
- Active strength
- 300 mg/15mL
- Pharmacologic classes
- Integrin Receptor Antagonist [EPC], Integrin Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TYRUKO
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NATALIZUMAB | 300 mg/15mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3JB47N2Q2P |
| Rxcui | 2725173, 2725180 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61314-543-94 | TYRUKO | 1 in 1 CARTON | INJECTION | 1 | | 13 |
| 61314-543-94 | TYRUKO | 15 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 15 | | 13 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 61314-543-94 | 61314054394 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61314-543-94) / 15 mL in 1 VIAL, SINGLE-DOSE | 2025-11-17 | No | No | Historical |