QALSODY
- Product NDC
- 64406-109
- 11-digit product format
- 644060109
- Labeler code
- 64406
- Product ID
- 64406-109_cd6631f3-a134-4743-81b1-ede10394e394
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tofersen
- Dosage form
- INJECTION
- Route
- INTRATHECAL
- Labeler
- Biogen Inc.
- Application
- NDA215887
- Marketing category
- NDA
- Marketing start
- 2023-04-25
- Substance
- TOFERSEN
- Active strength
- 100 mg/15mL
- Pharmacologic classes
- Antisense Oligonucleotide [EPC], Oligonucleotides, Antisense [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- QALSODY
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOFERSEN | 100 mg/15mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2NU6F9601K |
| Rxcui | 2634999, 2635005 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64406-109-01 | QALSODY | 15 mL in 1 VIAL, SINGLE-USE | INJECTION | 15 | | 3 |
| 64406-109-01 | QALSODY | 1 in 1 CARTON | INJECTION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64406-109 | QALSODY (TOFERSEN) INJECTION [BIOGEN INC.] | 3 | Current NDC, 2 package rows | 20241116_81356b45-1cb7-4eef-88ea-e44cc18b47c5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 64406-109-01 | 64406010901 | 1 VIAL, SINGLE-USE in 1 CARTON (64406-109-01) / 15 mL in 1 VIAL, SINGLE-USE | 2023-04-25 | No | No | Current |