Kisunla
- Product NDC
- 0002-9401
- 11-digit product format
- 000029401
- Labeler code
- 0002
- Product ID
- 0002-9401_85d3d68b-57f9-45e6-a1a7-fa19bc843f33
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- donanemab-azbt
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eli Lilly and Company
- Application
- BLA761248
- Marketing category
- BLA
- Marketing start
- 2024-07-02
- Substance
- DONANEMAB
- Active strength
- 17.5 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Kisunla
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DONANEMAB | 17.5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1ADB65P1KK |
| Rxcui | 2687972, 2687979 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0002-9401-01 | Kisunla | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 8 |
| 0002-9401-01 | Kisunla | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 20 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0002-9401 | KISUNLA (DONANEMAB-AZBT) INJECTION, SOLUTION [ELI LILLY AND COMPANY] | 4 | Current NDC, 2 package rows | 20240713_190352d4-ef62-4679-b4fa-e846e2766afa.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0002-9401-01 | 00002940101 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0002-9401-01) / 20 mL in 1 VIAL, SINGLE-DOSE | 2024-07-02 | No | No | Current |