zinplava

Generic: bezlotoxumab

Labeler: merck sharp & dohme llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name zinplava
Generic Name bezlotoxumab
Labeler merck sharp & dohme llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

bezlotoxumab 25 mg/mL

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0006-3025
Product ID 0006-3025_12338d29-efb0-4943-b5f5-826350e9ec46
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761046
Listing Expiration 2026-12-31
Marketing Start 2016-10-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00063025
Hyphenated Format 0006-3025

Supplemental Identifiers

RxCUI
1855052 1855057
UNII
4H5YMK1H2E

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zinplava (source: ndc)
Generic Name bezlotoxumab (source: ndc)
Application Number BLA761046 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0006-3025-00) / 40 mL in 1 VIAL, SINGLE-DOSE (0006-3025-01)
source: ndc

Packages (1)

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

Ingredients (1)

bezlotoxumab (25 mg/mL)

Linked Drug Pages (1)

ZINPLAVA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "12338d29-efb0-4943-b5f5-826350e9ec46", "openfda": {"unii": ["4H5YMK1H2E"], "rxcui": ["1855052", "1855057"], "spl_set_id": ["8f479bfe-2bfa-4cc5-9aee-1357364480b0"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0006-3025-00)  / 40 mL in 1 VIAL, SINGLE-DOSE (0006-3025-01)", "package_ndc": "0006-3025-00", "marketing_start_date": "20161021"}], "brand_name": "ZINPLAVA", "product_id": "0006-3025_12338d29-efb0-4943-b5f5-826350e9ec46", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "0006-3025", "generic_name": "bezlotoxumab", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZINPLAVA", "active_ingredients": [{"name": "BEZLOTOXUMAB", "strength": "25 mg/mL"}], "application_number": "BLA761046", "marketing_category": "BLA", "marketing_start_date": "20161021", "listing_expiration_date": "20261231"}