NDC 0006-3025

ZINPLAVA

Bezlotoxumab

ZINPLAVA is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Bezlotoxumab.

• Product ID: 0006-3025_376e6165-1156-47d0-b76d-1147b78dc119
• NDC: 0006-3025
• Product Type: Human Prescription Drug
• Proprietary Name: ZINPLAVA
• Generic Name: Bezlotoxumab
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-10-21
• Marketing Category: BLA / BLA
• Application Number: BLA761046
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: BEZLOTOXUMAB
• Active Ingredient Strength: 25 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0006-3025-00

1 VIAL, SINGLE-DOSE in 1 CARTON (0006-3025-00) > 40 mL in 1 VIAL, SINGLE-DOSE (0006-3025-01)

• Marketing Start Date: 2016-10-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0006-3025-01 [00006302501]

ZINPLAVA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761046
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-10-21

NDC 0006-3025-00 [00006302500]

ZINPLAVA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761046
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-10-21

Drug Details

Active Ingredients

Ingredient	Strength
BEZLOTOXUMAB	25 mg/mL

OpenFDA Data

• SPL SET ID: 8f479bfe-2bfa-4cc5-9aee-1357364480b0
• Manufacturer:
  • Merck Sharp & Dohme Corp.
• UNII:
  • 4H5YMK1H2E
• RxNorm Concept Unique ID - RxCUI:
  • 1855052
  • 1855057