TYSABRI
- Product NDC
- 64406-008
- 11-digit product format
- 644060008
- Labeler code
- 64406
- Product ID
- 64406-008_119c87a9-d153-4796-9525-694afdcdc1d6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- natalizumab
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Biogen Inc.
- Application
- BLA125104
- Marketing category
- BLA
- Marketing start
- 2004-11-23
- Substance
- NATALIZUMAB
- Active strength
- 300 mg/15mL
- Pharmacologic classes
- Integrin Receptor Antagonist [EPC], Integrin Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TYSABRI
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NATALIZUMAB | 300 mg/15mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3JB47N2Q2P |
| Rxcui | 477484, 603541 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64406-008-01 | TYSABRI | 1 in 1 CARTON | INJECTION | 1 | | 47 |
| 64406-008-01 | TYSABRI | 15 mL in 1 VIAL, SINGLE-USE | INJECTION | 15 | | 47 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64406-008 | TYSABRI (NATALIZUMAB) INJECTION [BIOGEN INC.] | 46 | Current NDC, Legacy NDC, 2 package rows | 20250323_c5fdde91-1989-4dd2-9129-4f3323ea2962.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64406-008-01 | 64406000801 | 1 VIAL, SINGLE-USE in 1 CARTON (64406-008-01) / 15 mL in 1 VIAL, SINGLE-USE | 2004-11-23 | 0000-00-00 | No | No | Current |