NDC 67919-030

ZERBAXA

Ceftolozane And Tazobactam

ZERBAXA is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Ceftolozane Sulfate; Tazobactam Sodium.

• Product ID: 67919-030_15b05ee2-b5bf-40e8-9282-2a4059ec0fe0
• NDC: 67919-030
• Product Type: Human Prescription Drug
• Proprietary Name: ZERBAXA
• Generic Name: Ceftolozane And Tazobactam
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-12-19
• Marketing Category: NDA / NDA
• Application Number: NDA206829
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
• Active Ingredient Strength: 1 g/10mL; g/10mL
• Pharm Classes: Cephalosporins [CS],Cephalosporin Antibacterial [EPC],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 67919-030-01

10 VIAL, SINGLE-DOSE in 1 CARTON (67919-030-01) > 10 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2014-12-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67919-030-01 [67919003001]

ZERBAXA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA206829
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-12-19

Drug Details

Active Ingredients

Ingredient	Strength
CEFTOLOZANE SULFATE	1 g/10mL

OpenFDA Data

• SPL SET ID: 70ac1d90-eff3-4f0b-9f46-5846c571b32f
• Manufacturer:
  • Merck Sharp & Dohme Corp.
• UNII:
  • UXA545ABTT
  • 7R247U84HY
• RxNorm Concept Unique ID - RxCUI:
  • 1597615
  • 1597620

Pharmacological Class

• Cephalosporins [CS]
• Cephalosporin Antibacterial [EPC]
• beta Lactamase Inhibitors [MoA]
• beta Lactamase Inhibitor [EPC]