cefazolin

Generic: cefazolin

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefazolin
Generic Name cefazolin
Labeler sandoz inc
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS PARENTERAL
Active Ingredients

cefazolin sodium 500 mg/1

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-3450
Product ID 0781-3450_05cd44b2-275f-44f5-b4f8-22393df834a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062831
Listing Expiration 2027-12-31
Marketing Start 1988-12-09

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07813450
Hyphenated Format 0781-3450

Supplemental Identifiers

RxCUI
1665050 1665052
UNII
P380M0454Z

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 cefazolin (source: ndc)
Generic Name cefazolin (source: ndc)
Application Number ANDA062831 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS PARENTERAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • HOW SUPPLIED Each vial of Cefazolin for Injection, USP contains cefazolin sodium equivalent to 500 mg or 1 gram cefazolin. NDC 0781-3450-95, 500 mg, carton of 10 vials NDC 0781-3451-96, 1 gram, carton of 25 vials NDC 0781-3451-95, 1 gram, carton of 10 vials As with other cephalosporins, Cefazolin for Injection, USP tends to darken depending on storage conditions; within the stated recommendations, however product potency is not adversely affected. Before reconstitution protect from light and store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Clinitest ® is a registered trademark of Miles, Inc. Clinistix ® is a registered trademark of Bayer Corporation. Revised: February 2025 46370476 Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540
  • 500 mg Carton NDC 0781-3450-95 Cefazolin for Injection, USP 500 mg per vial Rx Only For I.M. or I.V. use Sterile 10 x 500 mg Vials SANDOZ – A Novartis Division 500mg-carton
  • 1 g Carton NDC 0781-3451-95 Cefazolin for Injection, USP 1 gram per vial Rx Only For I.M. or I.V. use Sterile 10 x 1 g Vials SANDOZ 1g-carton
source: label

Packages (0)

No package records.

Ingredients (1)

cefazolin sodium (500 mg/1)

Linked Drug Pages (1)

Cefazolin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "PARENTERAL"], "spl_id": "05cd44b2-275f-44f5-b4f8-22393df834a1", "openfda": {"unii": ["P380M0454Z"], "rxcui": ["1665050", "1665052"], "spl_set_id": ["18e7366a-1b3e-4010-8f4a-dd559d4f2146"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Cefazolin", "product_id": "0781-3450_05cd44b2-275f-44f5-b4f8-22393df834a1", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "0781-3450", "generic_name": "Cefazolin", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cefazolin", "active_ingredients": [{"name": "CEFAZOLIN SODIUM", "strength": "500 mg/1"}], "application_number": "ANDA062831", "marketing_category": "ANDA", "marketing_start_date": "19881209", "listing_expiration_date": "20271231"}