NDC 71045-010

Zemdri (plazomicin)

Plazomicin

Zemdri (plazomicin) is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Achaogen, Inc.. The primary component is Plazomicin.

• Product ID: 71045-010_7803b863-697d-4d96-911f-5a229bbd8272
• NDC: 71045-010
• Product Type: Human Prescription Drug
• Proprietary Name: Zemdri (plazomicin)
• Generic Name: Plazomicin
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-07-16
• Marketing Category: NDA / NDA
• Application Number: NDA210303
• Labeler Name: Achaogen, Inc.
• Substance Name: PLAZOMICIN
• Active Ingredient Strength: 500 mg/10mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 71045-010-02

10 VIAL in 1 CARTON (71045-010-02) > 10 mL in 1 VIAL (71045-010-01)

• Marketing Start Date: 2018-07-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71045-010-01 [71045001001]

Zemdri (plazomicin) INJECTION

• Marketing Category: NDA
• Application Number: NDA210303
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-07-16

NDC 71045-010-02 [71045001002]

Zemdri (plazomicin) INJECTION

• Marketing Category: NDA
• Application Number: NDA210303
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-07-16

Drug Details

Active Ingredients

Ingredient	Strength
PLAZOMICIN	500 mg/10mL

OpenFDA Data

• SPL SET ID: 0b82ffed-27f4-4f5c-8135-670c148f0e12
• Manufacturer:
  • Achaogen, Inc.
• UNII:
  • LYO9XZ250J
• RxNorm Concept Unique ID - RxCUI:
  • 2049558
  • 2049553

NDC Crossover Matching brand name "Zemdri (plazomicin)" or generic name "Plazomicin"

NDC	Brand Name	Generic Name
69097-820	Zemdri (plazomicin)	Plazomicin
71045-010	Zemdri (plazomicin)	Plazomicin
80735-820	Zemdri (plazomicin)	Plazomicin