NDC 69097-820

Zemdri (plazomicin)

Plazomicin

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

• Product ID: 69097-820_7af6ce7b-5c29-445c-92ad-ce193e9a8c2c
• NDC: 69097-820
• 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: Cipla USA Inc.
• Substance Name: PLAZOMICIN
• Active Ingredient Strength: 500 mg/10mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 69097-820-96

10 VIAL in 1 CARTON (69097-820-96) > 10 mL in 1 VIAL (69097-820-37)

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

NDC SPL Data Element Entries

NDC 69097-820-37 [69097082037]

Zemdri (plazomicin) INJECTION

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

NDC 69097-820-96 [69097082096]

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

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