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Cefazolin

Cefazolin Sodium · Injection, Solution

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Cefazolin
Generic name
Cefazolin Sodium
Dosage form
Injection, Solution
Route
Intravenous
Marketing category
NDA · NDA
Labeler
Baxter Healthcare Corporation
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
3
Packages
3
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Cefazolin Sodium 1 g/50mL 1665050 View
Cefazolin Sodium 2 g/100mL 1665050 View
Cefazolin Sodium 3 g/150mL 1665050 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection, Solution
Route of administration
Intravenous
Presentations
6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Cephalosporin Antibacterial [EPC] EPC All 41 members
Cephalosporins [CS] CS All 41 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
207131
Application type
NDA · New Drug Application
Approval date
August 7, 2015
Sponsor
BAXTER HLTHCARE CORP
Products on application
3
Submissions recorded
9
Products approved under application 207131.
Product Trade name Form Strength Ingredient Status TE Flags
207131-001 CEFAZOLIN IN DEXTROSE SOLUTION CEFAZOLIN SODIUM Prescription — RLD RS
207131-002 CEFAZOLIN IN DEXTROSE SOLUTION CEFAZOLIN SODIUM Prescription — RLD RS
207131-003 CEFAZOLIN IN DEXTROSE SOLUTION CEFAZOLIN SODIUM Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 207131.
Type No. Action Status Date Review
Supplement 14 Labeling Approved August 31, 2026 Standard
Supplement 10 Efficacy Approved May 31, 2024 Standard
Supplement 9 Efficacy Approved February 1, 2024 Standard
Supplement 8 Labeling Approved September 20, 2021 Standard
Supplement 6 Efficacy Approved February 1, 2021 Standard
Supplement 3 Labeling Approved October 11, 2016 Standard
Supplement 2 Manufacturing (CMC) Approved August 1, 2016 Standard
Supplement 1 Manufacturing (CMC) Approved May 25, 2016 Standard
Original application 1 Type 5 - New Formulation or New Manufacturer Approved August 7, 2015 Standard

Review documents

  • 0 · Supplement · September 2, 2026
  • 0 · Supplement · September 1, 2026
  • 0 · Supplement · June 4, 2024
  • 0 · Supplement · June 3, 2024
  • 0 · Supplement · February 2, 2024
  • 0 · Supplement · February 2, 2024
  • 0 · Supplement · September 21, 2021
  • 0 · Supplement · February 5, 2021
  • 0 · Supplement · February 3, 2021
  • 0 · Supplement · February 22, 2017
  • 0 · Supplement · October 14, 2016
  • 0 · Original application · April 13, 2016
  • 0 · Original application · April 13, 2016
  • 0 · Original application · September 9, 2015
  • 0 · Original application · August 24, 2015

Adverse event reports

Source: openFDA FAERS
11,983
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: CEFAZOLIN SODIUM. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0338-0096-06 0338-0096 Baxter Healthcare Corporation 6 BAG in 1 CARTON (0338-0096-06) / 150 mL in 1 BAG May 31, 2024
0338-3503-41 0338-3503 Baxter Healthcare Corporation 24 BAG in 1 CARTON (0338-3503-41) / 50 mL in 1 BAG August 7, 2015
0338-3508-41 0338-3508 Baxter Healthcare Corporation 12 BAG in 1 CARTON (0338-3508-41) / 100 mL in 1 BAG August 7, 2015
0338-0096 0338-0096 Baxter Healthcare Corporation — May 31, 2024
0338-3503 0338-3503 Baxter Healthcare Corporation — August 7, 2015
0338-3508 0338-3508 Baxter Healthcare Corporation — August 7, 2015

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.