Suppliers and packagers for EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

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	EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	epinephrine bitartrate	SOLUTION;INTRAVENOUS	218475	NDA	Baxter Healthcare Corporation	0338-0006-20	20 BAG in 1 CARTON (0338-0006-20) / 250 mL in 1 BAG	2026-03-16
Baxter Hlthcare Corp	EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	epinephrine bitartrate	SOLUTION;INTRAVENOUS	218475	NDA	Baxter Healthcare Corporation	0338-0024-20	20 BAG in 1 CARTON (0338-0024-20) / 250 mL in 1 BAG	2025-02-28

Suppliers and packagers for EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

Last updated: June 16, 2026

Epinephrine Bitartrate in 0.9% Sodium Chloride Suppliers: Manufacturer List, Contract Supply, and Regulatory Supply Chain

Executive summary: Supply for epinephrine bitartrate in 0.9% sodium chloride (an injectable admixture) is typically split across (1) drug substance suppliers for epinephrine bitartrate, (2) finished-dose sterile injectable manufacturers (when commercially packaged product exists in-market), and (3) sterile compounding / admixture suppliers that produce 0.9% NaCl–based epinephrine admixtures for hospitals and wholesalers. Without a specific NDA/ANDA/BLA product identifier (or an FDA label/NDC), the supplier universe cannot be enumerated accurately for the exact marketed item.

Who supplies epinephrine bitartrate injection in 0.9% sodium chloride to hospitals and wholesalers?

Typical supplier categories

• Sterile injectables manufacturers: Companies that make epinephrine bitartrate sterile injection (single product) and, in some cases, distribute it as packaged product.
• Admixture/IV preparation providers (sterile compounding): Suppliers that prepare epinephrine in 0.9% sodium chloride as a compounded sterile admixture for institutional customers.
• Distributors/wholesalers: Firms that source from branded or generic sterile injectables producers and supply healthcare systems.

What determines the supplier list in practice

• Whether the product is sold as a commercially packaged finished injectable (identified by NDC), or whether it is prepared as a hospital/outsourced sterile compounding admixture.
• Whether the target is US supply (FDA-regulated sterile manufacturing plus FDA Drug Supply Chain Security Act distribution) or non-US markets.

How is supply usually structured for epinephrine admixtures?

• If there is no commercially packaged epinephrine bitartrate + 0.9% NaCl product, procurement is commonly:
  1. purchase epinephrine bitartrate sterile injection (or a concentrate),
  2. dilute in 0.9% sodium chloride either in-house pharmacy or via an outsourced sterile compounding supplier.

What are the main drug substance and sterile injectable supplier routes for epinephrine bitartrate?

Drug substance supply: epinephrine bitartrate API

• API for epinephrine bitartrate is supplied by specialty API manufacturers that sell to sterile injectable producers under DMF/ASMF filings and commercial contracts.
• Sterile injectable manufacturers then formulate into injectable presentations under their sterile manufacturing systems.

Finished-dose sterile injectable manufacturing

When a packaged finished product exists, the supplier is the NDA holder or generic/authorized manufacturer whose product is listed with an NDC and marketed through distribution channels.

Outsourced sterile compounding suppliers

For many hospitals, outsourced admixture suppliers prepare patient-specific or batch-based compounded products using:

• compounding facilities meeting USP <797> (sterile compounding) requirements and relevant quality controls,
• validation of preparation processes and sterility assurance programs.

Which companies supply epinephrine bitartrate sterile injection (and diluted 0.9% sodium chloride) in the US?

Data gap that blocks an accurate supplier table: To list specific companies as suppliers for the exact product and strength, the product must be tied to an FDA-labeled item by:

• NDC (preferred), or
• NDA/ANDA (or labeler) plus strength and dosage form, or
• a clearly defined compounded product specification (common in institutional procurement documents, not in a public database as a single “drug product”).

Without that identifier, supplier enumeration risks mixing:

• epinephrine bitartrate products that are not formulated with 0.9% NaCl,
• different concentrations,
• alternative salt forms or dosage units,
• non-US presentations.

What Orange Book listings and FDA registrations indicate supply coverage?

If the item is a packaged injectable

• The relevant source is the FDA Orange Book listing for the epinephrine bitartrate injectable.
• For suppliers, the most actionable fields are:
  • applicant/labeler,
  • dosage form,
  • strength,
  • patent and exclusivity status (which affects availability and competitive supply).

If the item is a compounded admixture

• Orange Book typically does not map one-to-one to compounded formulations.
• Supply comes from:
  • outsourced compounding pharmacies and
  • distributor networks sourcing sterile injectables and related components.

How do suppliers differ by strength, concentration, and container size?

Supplier qualification is concentration-sensitive:

• epinephrine bitartrate comes in multiple strengths and presentations (for example, multi-dose vials vs. single-dose ampules) across different markets.
• admixture in 0.9% sodium chloride changes:
  • concentration per mL,
  • stability and beyond-use dating (compounded),
  • container compatibility and adsorption considerations.

Commercial availability and supplier capability therefore depend on the exact specification used by purchasing organizations.

What documentation do procurement teams require from suppliers for epinephrine admixtures?

For institutional buying, supplier packets usually include:

• Certificate of Analysis (CoA) and batch records,
• sterility and endotoxin documentation (as applicable),
• packaging and labeling specs,
• USP compliance references for sterile manufacturing processes (for packaged products),
• compounding process validation and sterility assurance documentation (for compounded products).

Commercial supply risk: what shortages or allocation scenarios affect epinephrine availability?

Epinephrine-based injectables frequently face:

• manufacturing site constraints for sterile production capacity,
• API supply variability for specialty APIs,
• regulatory and inspection events that can affect release timelines.

For a specific product line (epinephrine bitartrate + 0.9% NaCl), supply risk analysis must anchor to:

• the exact marketed NDC or compounding SOP product definition,
• current distribution status in the supply chain.

Key takeaways

• Supplier identification for “epinephrine bitartrate in 0.9% sodium chloride” requires the exact product identifier. In practice, the supply chain is either a packaged sterile injectable (NDC-based) or an outsourced/in-house sterile admixture (spec-based).
• Public FDA databases map cleanly to packaged products (Orange Book, labeler/NDC). They do not reliably map to compounded admixtures prepared as dilutions in 0.9% NaCl without an explicit product identifier.
• Procurement teams should structure sourcing around:
  • NDC/NDA/ANDA for packaged supply, or
  • compounding specification plus sterility and quality documentation for admixture supply.

FAQs

1. Do suppliers list “epinephrine bitartrate in 0.9% sodium chloride” as a single commercial drug product?
   Only when there is a packaged, labeled finished injectable that specifies that admixture formulation. Otherwise it is commonly prepared by compounding from an epinephrine bitartrate injection concentrate.

2. Which dataset is best to find suppliers for epinephrine bitartrate injectable in the US?
   The FDA Orange Book / drug product listings for packaged dosage forms keyed to NDC and labeler.

3. Who typically supplies compounded epinephrine in 0.9% NaCl to healthcare systems?
   Outsourced sterile compounding pharmacies and sterile compounding divisions of institutional pharmacy networks, plus wholesalers distributing the underlying sterile injection concentrate used for dilution.

4. How does strength affect supplier qualification for epinephrine admixtures?
   Strength drives compatibility, stability, and beyond-use dating, so suppliers are qualified per exact concentration and container.

5. What supplier documents matter most for sterile epinephrine preparations?
   CoA, sterility/endotoxin evidence, labeling, and manufacturing or compounding batch traceability aligned to sterile quality systems.

References

(No sources provided in the prompt that allow citation of specific supplier names for the exact product.)