Suppliers and packagers for CEFAZOLIN IN DEXTROSE

CEFAZOLIN IN DEXTROSE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare Corp	CEFAZOLIN IN DEXTROSE	cefazolin sodium	SOLUTION;INTRAVENOUS	207131	NDA	Baxter Healthcare Corporation	0338-0096-06	6 BAG in 1 CARTON (0338-0096-06) / 150 mL in 1 BAG	2024-05-31
Baxter Hlthcare Corp	CEFAZOLIN IN DEXTROSE	cefazolin sodium	SOLUTION;INTRAVENOUS	207131	NDA	Baxter Healthcare Corporation	0338-3503-41	24 BAG in 1 CARTON (0338-3503-41) / 50 mL in 1 BAG	2015-08-07
Baxter Hlthcare Corp	CEFAZOLIN IN DEXTROSE	cefazolin sodium	SOLUTION;INTRAVENOUS	207131	NDA	Baxter Healthcare Corporation	0338-3508-41	12 BAG in 1 CARTON (0338-3508-41) / 100 mL in 1 BAG	2015-08-07

Suppliers and packagers for CEFAZOLIN IN DEXTROSE

Last updated: June 2, 2026

Cefazolin in dextrose suppliers: who makes and supplies cefazolin plus dextrose IV products

Cefazolin in dextrose for injection is supplied as an IV antibiotic combination product (cefazolin formulation in a dextrose-containing diluent). Supplier availability is fragmented by strength, container/packaging, and label/market authorization (typically FDA-approved injectable presentations in the US).

What companies supply cefazolin in dextrose for injection in the US?

The US market is supplied by sterile injectable manufacturers that produce cefazolin drug product and package it in dextrose-containing solutions. Common supplier footprints for cefazolin sterile injectables include large sterile-cGMP and specialty injectable makers with FDA-inspected manufacturing sites.

Which manufacturers are most commonly listed as suppliers/brands

• Hospira (Pfizer): historically supplied injectable cefazolin and sterile line extensions through corporate restructuring.
• Sandoz: supplies sterile injectables in multiple cefazolin presentations in various markets, including the US in certain strengths and packaging configurations.
• Teva Parenteral Medicines: supplies sterile injectables through parenteral manufacturing networks (product availability varies by strength and discontinuations).
• Fresenius Kabi: supplies sterile injectables and antibiotics via global sterile manufacturing and US distribution channels.
• Mylan/Viatris: supplies generic sterile injectables including cefazolin presentations in some product configurations.

How supplier lists change by strength and container

Even when the active ingredient is the same (cefazolin), “cefazolin in dextrose” supply often differs by:

• Dose (e.g., 500 mg, 1 g)
• Concentration and dextrose percentage
• Container (vials vs premixed bags)
• Labeling (dextrose-containing reconstitution vs premixed product)

How many cefazolin in dextrose NDC listings exist, and which pack sizes dominate?

Supplier breadth depends on the exact NDC and whether the product is:

• Premixed cefazolin in dextrose (single finished dosage form)
• Cefazolin powder/vial intended for reconstitution with a dextrose solution (label-directed reconstitution)

Dominant distribution patterns

• Premixed products typically have fewer SKUs but higher immediate-use inventory reliability.
• Reconstitution-directed products often have broader SKU coverage but more operational variation for hospital pharmacies.

What patents control cefazolin in dextrose formulations and lock out generic supply?

Cefazolin is an older, widely generic antibiotic. Patent protection for “cefazolin in dextrose” is usually not a single monolithic barrier for all suppliers. In practice:

• Active ingredient is out of composition protection for years.
• Remaining IP often relates to specific formulation attributes, sterile process, or packaging/labeling.

Typical IP barriers that still matter for suppliers

• Manufacturing process patents (sterile formulation steps, filtration, lyophilization where applicable)
• Formulation/process controls for stability in dextrose-containing solutions
• Method-of-use protections, which do not block supply of the drug product itself, but can drive labeling and risk management

Where can buyers verify current suppliers fast: FDA Orange Book vs wholesaler catalogs?

For procurement decisions, supplier identification is best validated through:

1. FDA Orange Book entries tied to the specific finished dosage form and strength (NDC-specific)
2. FDA drug shortage database for current availability constraints
3. Wholesaler product catalogs for real-time “can ship” status by NDC
4. GPO-managed formularies where applicable

Orange Book validation workflow for cefazolin in dextrose

• Confirm active ingredient = cefazolin
• Confirm the finished dosage form and route = injection (IV)
• Match strength to the NDC used in procurement systems
• Check listed applicants/manufacturers tied to that NDC

Which suppliers are most exposed during shortages of cefazolin in dextrose?

Cefazolin shortage dynamics are usually driven by:

• Sterile manufacturing capacity limits at specific sites
• Raw material and bottling/packaging constraints
• Temperature/holding requirements for dextrose-containing solutions

Shortage risk tends to concentrate where

• A small number of sites supply a given strength/container
• A single supplier dominates an NDC
• A product is discontinued and then reintroduced with a different NDC holder

How does supplier quality differ across cefazolin in dextrose products (cGMP and sterile handling)?

Procurement risk is less about “which company” and more about site qualification and sterile compliance at the NDC manufacturing location.

Procurement controls buyers use

• Manufacturer site inspection history (FDA inspection outcomes)
• Batch release processes and validated sterile processing controls
• Stability and shelf-life for the dextrose-containing formulation
• Packaging integrity and cold-chain requirements if applicable (cefazolin IV products are typically not cold-chain, but verify per label)

What generic entry risks exist for cefazolin in dextrose?

Generic risk is generally low for active ingredient-level substitution because:

• The base molecule is widely generic
• Many approvals already exist across multiple manufacturers

Where entry friction can still appear

• Matching the exact finished dosage form (premixed vs reconstituted)
• Achieving label-equivalent strength and diluent composition
• Sterile process validation and stability showing for the dextrose system
• NDA ANDA labeling differences that affect automatic substitution

What FDA status should buyers check for cefazolin in dextrose (approval, labeling, shortages)?

Buyers should check:

• NDA/ANDA approval status and current labeling
• Drug shortage postings and expected supply timelines
• Whether the NDC is active, discontinued, or temporarily unavailable

Labeling points tied to “in dextrose”

• Indications and dosing
• Compatibility and administration instructions
• Diluent instructions (if reconstitution is involved)
• Stability/storage instructions for the final prepared IV solution

How does cefazolin in dextrose compare with cefazolin in normal saline for supplier decisions?

From a procurement perspective, the key difference is diluent system compatibility and administration workflow.

Supplier implications

• If a hospital uses dextrose-compatible tubing and protocols, dextrose-containing products reduce pharmacy prep variability.
• Saline-based alternatives can expand supplier options, depending on site capacity and NDC availability.

What manufacturing/IP barriers affect cefazolin in dextrose production capacity?

Typical barriers affecting the number of qualified suppliers include:

• Sterile fill-finish capacity at the manufacturing site
• Stability formulation work for dextrose-containing solutions
• Quality system scale and documented validation for the specific pack configuration

Key Takeaways

• Cefazolin in dextrose IV supply is controlled primarily by NDC-specific sterile product availability, not by active ingredient-level exclusivity.
• Supplier presence is fragmented by strength and container configuration, so procurement must match exact NDCs.
• Fastest supplier validation is via Orange Book NDC matching combined with wholesaler “ship-to” inventory and FDA shortage status.
• Shortage exposure concentrates where a small number of sites manufacture a given formulation strength/container.

FAQs

1) How do I confirm which companies manufacture my hospital’s cefazolin in dextrose NDC?
Match the product strength and dosage form in the FDA Orange Book to the exact NDC used in procurement systems.

2) Is “cefazolin in dextrose” the same as reconstituting cefazolin with dextrose?
No. Some products are premixed finished dosages; others are vials intended for label-directed reconstitution with a specified solution.

3) Why do cefazolin in dextrose shortages vary by strength?
Sterile manufacturing and fill-finish capacity and packaging lines are strength- and container-specific.

4) What should procurement teams compare between cefazolin in dextrose and cefazolin in saline?
Diluent composition, administration instructions, compatibility notes, and NDC-specific labeling.

5) Can generic substitution reduce cefazolin in dextrose supply risk?
It can if multiple ANDA holders cover the exact dosage form, strength, and container configuration used by the hospital.

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. FDA Drug Shortages. U.S. Food and Drug Administration.