CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Samson Medcl	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	cefepime hydrochloride	POWDER;INTRAVENOUS	209408	ANDA	SAMSON MEDICAL TECHNOLOGIES LLC	66288-8100-1	1 BAG in 1 BAG (66288-8100-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BAG	2018-10-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: June 15, 2026

Cefepime hydrochloride in plastic containers is supplied through (1) branded sterile injectables manufacturers with Abbreviated New Drug Application (ANDA) capabilities and (2) contract sterile-fill-finish (C(S)FF) suppliers that produce cefepime drug product under license or toll manufacture.

What companies supply cefepime hydrochloride injection in plastic containers?

Short answer: The US market is served by multiple ANDA/brand suppliers; many plastic-container SKUs are made via sterile fill-finish networks using pre-sterilized plastic components and validated aseptic processes. The primary supplier set is identifiable by Orange Book listings for “cefepime hydrochloride for injection” and by label/packaging information on approved products (plastic container, bag-based, or prefilled device formats).

What product forms count as “plastic container” for cefepime?

Plastic-container cefepime injectables generally fall into these packaging categories:

Plastic bag/administration container (common for IV antibiotics)
Pre-mixed or device-based plastic container (less common than bags, but present depending on label format)
Other plastic primary packaging used for sterile parenterals

How to identify suppliers by packaging on approved labels

For each supplier, the clearest way to validate “plastic container” is to cross-check:

NDC label text for package type (plastic container/bag)
FDA label section describing container closure system
Orange Book “dosage form” and product description correlated with NDCs

Because the supplier list is NDC- and packaging-specific, a complete, actionable supplier roster requires Orange Book-to-NDC confirmation for plastic-container presentations.

Which suppliers have FDA-approved cefepime hydrochloride products for IV use?

Short answer: FDA-approved cefepime hydrochloride products are distributed by multiple companies with ANDAs and/or brand authorization, each with distinct NDCs. “Plastic container” is not a universal trait across all cefepime strengths and presentations.

What to check in Orange Book for cefepime hydrochloride

Active ingredient: cefepime hydrochloride
Dosage form: for injection
Strength and container type tied to NDC
Application type: ANDA/505(b)(1) as applicable

Which strengths commonly appear in plastic container SKUs

Plastic-container presentations are typically offered at common IV antibiotic strengths. Exact strength coverage depends on each supplier’s approved NDC set.

How many cefepime hydrochloride plastic-container suppliers exist in the US?

Short answer: Multiple ANDA/brand listings exist for cefepime hydrochloride injection, but the number of suppliers specifically for plastic-container presentations is smaller because each supplier’s packaging portfolio differs by NDC.

Why the count varies

Some suppliers offer only vials rather than bags
Others offer plastic containers only for selected strengths
Packaging can shift across product lifecycle (manufacturing updates, NDC refreshes)

What are the key contract manufacturing and sterile fill-finish pathways for cefepime in plastic containers?

Short answer: Cefepime plastic-container products typically follow one of two models:

Direct manufacture by an integrated sterile injectable manufacturer with aseptic filling and container prep
C(S)FF/toll fill-finish with sterile manufacturing executed by a contract partner under the NDA/ANDA holder’s control

How plastic-container manufacturing is structured

Key steps:

API-to-bulk formulation under GMP
Aseptic compounding and sterile filtration
Aseptic filling into plastic containers
Container closure integrity testing
Terminal sterilization or aseptic processing validation depending on product design
Labeling and serialization (where applicable)

What procurement and qualification risks exist for cefepime hydrochloride in plastic containers?

Short answer: Supply continuity is the main risk, driven by:

Single-site manufacturing dependence for certain NDCs
Sterile manufacturing capacity constraints
Packaging-component supply (plastic container components, closures)
Batch release variability and sterility assurance requirements

What buyers typically qualify

Equivalent NDC and packaging configuration
Sterile manufacturing site and change history
Release specifications and chain-of-custody
Expiry dating, stability, and transport requirements

Are there separate suppliers for cefepime plastic-container bags vs vials?

Short answer: Yes. Even if the same sponsor company markets both vials and plastic containers, different NDCs and often different manufacturing lines or fill-finish sites are used.

Implication for sourcing

Procurement teams should treat:

Plastic-container NDCs as distinct SKUs, not interchangeable with vial NDCs
Qualification for line and container is required for compliant substitution

How does cefepime packaging affect FDA regulatory status and interchangeability?

Short answer: Packaging type is tied to the approved product (NDC and label). Interchangeability is assessed at the level of:

Approved drug product identity
Strength
Dosage form
Container closure system
Labeling instructions for preparation and administration

Orange Book and label alignment

For any supplier being evaluated, the approved listing should match:

NDC
Label container type
Dosage form
Strength

What is the competitive landscape for cefepime hydrochloride in plastic containers?

Short answer: Competition comes from:

ANDA entrants with sterile fill-finish capacity
Established sterile injectable firms with multiple NDCs
Potential upstream packaging or C(S)FF providers that enable parallel supply

How to map competition by NDC

A practical competitive map is built by:

Listing all approved cefepime hydrochloride injection NDCs
Filtering to those explicitly described as plastic-container presentations
Assigning each NDC to the labeler/manufacturer and application holder

Key Takeaways

Cefepime hydrochloride in plastic containers is supplied by multiple FDA-approved product holders, but plastic-container SKUs are not universal across all cefepime ANDA offerings.
Supplier identification must be NDC- and packaging-specific, verified via FDA label container closure descriptions and Orange Book entries.
Supply risk is driven by sterile fill-finish capacity and plastic packaging component availability, so qualification should be tied to the exact plastic-container NDC.

FAQs

Which NDCs of cefepime hydrochloride injection are packaged in plastic containers?
Can a cefepime hydrochloride vial be substituted for a plastic-container presentation by NDC equivalence?
Who are the contract sterile fill-finish partners for cefepime bags in the US?
What label elements confirm the container closure system for cefepime plastic-container products?
How do shortages typically impact plastic-container cefepime NDCs compared with vials?

References

(No sources were provided in the prompt, and no citations can be generated without specific supplier/Orange Book/NDC data.)

Suppliers and packagers for CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER