Home NDC 50242-103 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 UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination KG6VO684Z6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2174095 Internal RxNorm lookup 2174100 Internal RxNorm lookup 2398131 Internal RxNorm lookup 2398133 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761121 Polivy polatuzumab vedotin-piiq 351(a) Rx 2026-06-01
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