Home NDC 69097-820 Zemdri (plazomicin)
Product NDC 69097-820
11-digit product format 690970820
Labeler code 69097
Product ID 69097-820_b2d9319a-6c34-4851-8486-3d956e916f53
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Plazomicin
Dosage form INJECTION
Route INTRAVENOUS
Labeler Cipla USA 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 69097-820-37 Zemdri (plazomicin) 10 mL in 1 VIAL INJECTION 10 4 69097-820-96 Zemdri (plazomicin) 10 in 1 CARTON INJECTION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-820 ZEMDRI (PLAZOMICIN) (PLAZOMICIN) INJECTION [CIPLA USA INC.] 4 Current NDC, Legacy NDC, 2 package rows 20241222_eccf9fd9-53ac-4252-a106-5567b3a82a70.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 69097-820-37 69097082037 10 mL in 1 VIAL 10 ml Historical 69097-820-96 69097082096 10 VIAL in 1 CARTON (69097-820-96) / 10 mL in 1 VIAL (69097-820-37) 10 vial 2018-07-16 0000-00-00 No No Current