Home NDC 71045-010 Zemdri (plazomicin)
Product NDC 71045-010
11-digit product format 710450010
Labeler code 71045
Product ID 71045-010_7803b863-697d-4d96-911f-5a229bbd8272
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Plazomicin
Dosage form INJECTION
Route INTRAVENOUS
Labeler Achaogen, 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 71045-010-01 Zemdri (plazomicin) 10 mL in 1 VIAL INJECTION 10 1 71045-010-02 Zemdri (plazomicin) 10 in 1 CARTON INJECTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71045-010 ZEMDRI (PLAZOMICIN) (PLAZOMICIN) INJECTION [ACHAOGEN, INC.] 1 Current NDC, Legacy NDC, 2 package rows 20180716_0b82ffed-27f4-4f5c-8135-670c148f0e12.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 71045-010-01 71045001001 10 mL in 1 VIAL 10 ml Historical 71045-010-02 71045001002 10 VIAL in 1 CARTON (71045-010-02) / 10 mL in 1 VIAL (71045-010-01) 10 vial 2018-07-16 0000-00-00 No No Current