IMAAVY
- Product NDC
- 57894-800
- 11-digit product format
- 578940800
- Labeler code
- 57894
- Product ID
- 57894-800_d235e5b0-4de6-4235-92ef-ed05fa5892b2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nipocalimab-aahu
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Janssen Biotech, Inc.
- Application
- BLA761430
- Marketing category
- BLA
- Marketing start
- 2025-04-29
- Substance
- NIPOCALIMAB
- Active strength
- 185 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- IMAAVY
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NIPOCALIMAB | 185 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 87M90CV8NC |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57894-800-01 | IMAAVY | 1.62 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION, CONCENTRATE | 1.62 | | 4 |
| 57894-800-01 | IMAAVY | 1 in 1 BOX | INJECTION, SOLUTION, CONCENTRATE | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57894-800 | IMAAVY (NIPOCALIMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.] | 2 | Current NDC, 2 package rows | 20250507_8886274c-f2b2-48af-85c1-2f90bfe304b8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 57894-800-01 | 57894080001 | 1 VIAL, SINGLE-DOSE in 1 BOX (57894-800-01) / 1.62 mL in 1 VIAL, SINGLE-DOSE | 2025-04-29 | No | No | Current |