Home NDC 80735-820 Zemdri (plazomicin)
Product NDC 80735-820
11-digit product format 807350820
Labeler code 80735
Product ID 80735-820_2b813678-540b-41e8-bed5-609cc99fd663
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Plazomicin
Dosage form INJECTION
Route INTRAVENOUS
Labeler Cipla Therapeutics Inc.
Application NDA210303
Marketing category NDA
Marketing start 2018-07-16
Substance PLAZOMICIN
Active strength 500 mg/10mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Zemdri (plazomicin)
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PLAZOMICIN 500 mg/10mL
Harmonized Identifiers# Field, Values table Field Values Unii LYO9XZ250J Rxcui 2049553, 2049558
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80735-820-37 Zemdri (plazomicin) 10 mL in 1 VIAL INJECTION 10 2 80735-820-96 Zemdri (plazomicin) 10 in 1 CARTON INJECTION 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80735-820 ZEMDRI (PLAZOMICIN) (PLAZOMICIN) INJECTION [CIPLA THERAPEUTICS INC.] 2 Current NDC, Legacy NDC, 2 package rows 20230228_1243fcd3-de84-428b-901e-d83d65e4d98c.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 80735-820-37 80735082037 10 mL in 1 VIAL 10 ml Historical 80735-820-96 80735082096 10 VIAL in 1 CARTON (80735-820-96) / 10 mL in 1 VIAL (80735-820-37) 10 vial 2018-07-16 0000-00-00 No No Current