ZYNYZ
- Product NDC
- 50881-006
- 11-digit product format
- 508810006
- Labeler code
- 50881
- Product ID
- 50881-006_4b5a0ce6-7f12-44aa-9b45-05188a37da9d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- retifanlimab-dlwr
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Incyte Corporation
- Application
- BLA761334
- Marketing category
- BLA
- Marketing start
- 2023-03-22
- Substance
- RETIFANLIMAB
- Active strength
- 25 mg/mL
- Pharmacologic classes
- Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ZYNYZ
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RETIFANLIMAB | 25 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2Y3T5IF01Z |
| Rxcui | 2632985, 2632991 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50881-006-03 | ZYNYZ | 1 in 1 CARTON | INJECTION | 1 | | 16 |
| 50881-006-03 | ZYNYZ | 20 mL in 1 VIAL, SINGLE-USE | INJECTION | 20 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50881-006 | ZYNYZ (RETIFANLIMAB-DLWR) INJECTION [INCYTE CORPORATION] | 7 | Current NDC, 2 package rows | 20240418_109648d0-d30a-42fc-8273-39cb1540a751.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50881-006-03 | 50881000603 | 1 VIAL, SINGLE-USE in 1 CARTON (50881-006-03) / 20 mL in 1 VIAL, SINGLE-USE | 2023-03-22 | No | No | Historical |