Home NDC 68727-712 ZEPZELCA
Product NDC 68727-712
11-digit product format 687270712
Labeler code 68727
Product ID 68727-712_846f5d71-faab-42a5-85d6-d83626b7bf3c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lurbinectedin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Jazz Pharmaceuticals, Inc.
Application NDA213702
Marketing category NDA
Marketing start 2020-06-15
Substance LURBINECTEDIN
Active strength .5 mg/mL
Pharmacologic classes Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base ZEPZELCA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LURBINECTEDIN .5 mg/mL
Harmonized Identifiers# Field, Values table Field Values Unii 2CN60TN6ZS Rxcui 2374733, 2374738
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68727-712-01 ZEPZELCA 8 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 8 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68727-712 ZEPZELCA (LURBINECTEDIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JAZZ PHARMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 1 package rows 20250515_632bb50c-3bcb-4c85-9056-fc33410550ae.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 68727-712-01 68727071201 8 mL in 1 VIAL, SINGLE-DOSE (68727-712-01) 8 ml 2020-06-15 0000-00-00 No No Current