MONJUVI
- Product NDC
- 50881-013
- 11-digit product format
- 508810013
- Labeler code
- 50881
- Product ID
- 50881-013_a70f85e0-c22b-419a-9be2-51f575932633
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tafasitamab-cxix
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Incyte Corporation
- Application
- BLA761163
- Marketing category
- BLA
- Marketing start
- 2020-08-05
- Substance
- TAFASITAMAB
- Active strength
- 200 mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MONJUVI
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TAFASITAMAB | 200 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QQA9MLH692 |
| Rxcui | 2387338, 2387343 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50881-013-03 | MONJUVI | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | | 12 |
| 50881-013-03 | MONJUVI | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50881-013 | MONJUVI (TAFASITAMAB-CXIX) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [INCYTE CORPORATION] | 6 | Current NDC, 2 package rows | 20250131_9e0a220b-517f-4c86-b581-ffbab493fb58.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50881-013-03 | 50881001303 | 1 VIAL in 1 CARTON (50881-013-03) / 5 mL in 1 VIAL | 1 vial | 2020-08-05 | No | No | Historical |