POLIVY
- Product NDC
- 50242-103
- 11-digit product format
- 502420103
- Labeler code
- 50242
- Product ID
- 50242-103_6e6d980b-007b-4e04-b908-dd456f137d15
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- polatuzumab vedotin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Genentech, Inc.
- Application
- BLA761121
- Marketing category
- BLA
- Marketing start
- 2019-06-10
- Substance
- POLATUZUMAB VEDOTIN
- Active strength
- 30 mg/1.88mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- POLIVY
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POLATUZUMAB VEDOTIN | 30 mg/1.88mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KG6VO684Z6 |
| Rxcui | 2174095, 2174100, 2398131, 2398133 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50242-103-01 | POLIVY | 6 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 6 | | 14 |
| 50242-103-01 | POLIVY | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50242-103 | POLIVY (POLATUZUMAB VEDOTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20241206_20a16ab2-f338-4abb-9dcd-254bd949a2bc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50242-103-01 | 50242010301 | 1 VIAL in 1 CARTON (50242-103-01) / 6 mL in 1 VIAL | 1 vial | 2020-09-18 | 0000-00-00 | No | No | Current |