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NDC 00006-3025-00 ZINPLAVA 25 mg/mL Details
ZINPLAVA 25 mg/mL
ZINPLAVA is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Merck Sharp & Dohme LLC. The primary component is BEZLOTOXUMAB.
MedlinePlus Drug Summary
Bezlotoxumab injection is used to decrease the risk of Clostridium difficile infection (C. difficile or CDI; a type of bacteria that can cause severe or life-threatening diarrhea) from coming back in people who are at high risk for C. difficile infection and who are already taking an antibiotic drug to treat Clostridium difficile. Bezlotoxumab is in a class of medications called monoclonal antibodies. It works by binding to a C. difficile toxin to stop its effects on the body.
Related Packages: 00006-3025-00Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bezlotoxumab Injection
Product Information
| NDC | 00006-3025 |
|---|---|
| Product ID | 0006-3025_10a116c7-454f-42f0-8519-05ae60cc8791 |
| Associated GPIs | 19503015002020 |
| GCN Sequence Number | 076789 |
| GCN Sequence Number Description | bezlotoxumab VIAL 1000 MG/40 INTRAVEN |
| HIC3 | W2H |
| HIC3 Description | ANTIBACTERIAL MONOCLONAL ANTIBODIES |
| GCN | 42584 |
| HICL Sequence Number | 043884 |
| HICL Sequence Number Description | BEZLOTOXUMAB |
| Brand/Generic | Brand |
| Proprietary Name | ZINPLAVA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | bezlotoxumab |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 25 |
| Active Ingredient Units | mg/mL |
| Substance Name | BEZLOTOXUMAB |
| Labeler Name | Merck Sharp & Dohme LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA761046 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00006-3025-00 (00006302500)
| NDC Package Code | 0006-3025-00 |
|---|---|
| Billing NDC | 00006302500 |
| Package | 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 |
| Pricing Information | N/A |