Piasky
- Product NDC
- 50242-115
- 11-digit product format
- 502420115
- Labeler code
- 50242
- Product ID
- 50242-115_04e8fab1-279a-466a-a2cf-52a0f9e550bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Crovalimab
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Genentech, Inc.
- Application
- BLA761388
- Marketing category
- BLA
- Marketing start
- 2024-06-20
- Substance
- CROVALIMAB
- Active strength
- 340 mg/2mL
- Pharmacologic classes
- Complement C5 Inhibitor [EPC], Complement C5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Piasky
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CROVALIMAB | 340 mg/2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H9KH1GP3UU |
| Rxcui | 2686626, 2686633 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50242-115-01 | Piasky | 2 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 2 | | 3 |
| 50242-115-01 | Piasky | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50242-115 | PIASKY (CROVALIMAB) INJECTION, SOLUTION [GENENTECH, INC.] | 1 | Current NDC, 2 package rows | 20240704_2597efc2-a97b-487c-b500-a67fd282a73b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50242-115-01 | 50242011501 | 1 VIAL, SINGLE-USE in 1 CARTON (50242-115-01) / 2 mL in 1 VIAL, SINGLE-USE | 2024-06-20 | No | No | Historical |