AVLAYAH
- Product NDC
- 84976-001
- 11-digit product format
- 849760001
- Labeler code
- 84976
- Product ID
- 84976-001_352edb2c-39aa-4955-b456-f5c731b746d0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tividenofusp alfa-eknm
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Denali Therapeutics Inc.
- Application
- BLA761485
- Marketing category
- BLA
- Marketing start
- 2026-04-06
- Substance
- TIVIDENOFUSP ALFA
- Active strength
- 150 mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AVLAYAH
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TIVIDENOFUSP ALFA | 150 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QLD7UJN8CF |
| Rxcui | 2740019, 2740025 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84976-001-01 | AVLAYAH | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
| 84976-001-01 | AVLAYAH | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84976-001-01 | 84976000101 | 1 VIAL in 1 CARTON (84976-001-01) / 5 mL in 1 VIAL | 1 vial | 2026-04-06 | No | No | Current |