Rybrevant
- Product NDC
- 57894-501
- 11-digit product format
- 578940501
- Labeler code
- 57894
- Product ID
- 57894-501_504da886-86ad-400c-8f0c-e503497de5e0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amivantamab-vmjw
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Janssen Biotech, Inc.
- Application
- BLA761210
- Marketing category
- BLA
- Marketing start
- 2021-05-21
- Substance
- AMIVANTAMAB
- Active strength
- 350 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rybrevant
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMIVANTAMAB | 350 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0JSR7Z0NB6 |
| Rxcui | 2549734, 2549739 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57894-501-00 | Rybrevant | 1 in 1 VIAL, SINGLE-USE | INJECTION | 1 | | 16 |
| 57894-501-01 | Rybrevant | 1 in 1 CARTON | INJECTION | 1 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57894-501 | RYBREVANT (AMIVANTAMAB) INJECTION [JANSSEN BIOTECH, INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20250228_1466c070-9f97-4fa4-a955-6a6b59981fb8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57894-501-00 | 57894050100 | 1 in 1 VIAL, SINGLE-USE | | | | | Historical |
| 57894-501-01 | 57894050101 | 1 VIAL, SINGLE-USE in 1 CARTON (57894-501-01) / 1 INJECTION in 1 VIAL, SINGLE-USE (57894-501-00) | 2021-05-21 | 0000-00-00 | No | No | Current |