MARCAINE HYDROCHLORIDE PRESERVATIVE FREE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hospira	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	016964	NDA	Henry Schein, Inc.	0404-9768-30	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9768-30) / 30 mL in 1 VIAL, SINGLE-DOSE	2026-01-26
Hospira	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	016964	NDA	Henry Schein, Inc.	0404-9770-10	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9770-10) / 10 mL in 1 VIAL, SINGLE-DOSE	2025-12-02
Hospira	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	016964	NDA	Henry Schein, Inc.	0404-9908-30	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9908-30) / 30 mL in 1 VIAL, SINGLE-DOSE	2022-01-13
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: June 2, 2026

MARCAINE HYDROCHLORIDE PRESERVATIVE FREE Suppliers: Who Manufactures, Supplies, and Distributes the Bupivacaine Product?

Suppliers for Marcaine Hydrochloride Preservative Free are driven by (1) the branded owner’s supply chain and (2) the availability of equivalent bupivacaine hydrochloride injectable products that are marketed through wholesale distribution. The branded product’s market presence is typically maintained through the manufacturer/distributor network listed in FDA labeling and commercial channels.

Direct supplier and distribution view: branded and hospital-system supply flows through the original manufacturer and GPO-aligned wholesalers (McKesson, Cardinal Health, AmerisourceBergen), with secondary distribution via regional wholesalers and authorized distributors.

What active ingredient and dosage form does Marcaine Hydrochloride Preservative Free use?

Marcaine Hydrochloride Preservative Free is bupivacaine hydrochloride supplied as an injectable formulation intended for local or regional anesthesia. The “preservative free” designation aligns with use cases where preservative components are avoided in intraoperative and catheter-based administration settings.

What labels and supply terms matter for procurement?

Procurement and supplier qualification typically require:

NDC match (labeler/manufacturer changes can occur across presentations)
Lot-level CoA and sterility assurance documentation
Storage conditions and temperature excursion policies
GPO contract alignment and wholesale channel authorization

Which supply constraints drive supplier switching?

Hospital pharmacy substitution often occurs when:

branded inventory is constrained,
a particular NDC is backordered,
contract pricing favors alternate presentations of bupivacaine hydrochloride injection.

Who are the main pharmaceutical suppliers and distributors for Marcaine Hydrochloride Preservative Free in the US?

Answer: In US channels, supply is routed through the product’s manufacturer/labeler and then to wholesalers that serve hospitals and health systems, most commonly:

McKesson Corporation
Cardinal Health
AmerisourceBergen (now tied to Cencora)

From there, distribution reaches:

hospital pharmacies
surgery centers
group purchasing organizations (GPO) aligned with the wholesalers’ contracted pricing.

How do wholesalers source the branded Marcaine presentation?

Wholesalers typically source branded injectables through:

manufacturer direct shipments to wholesaler warehouses, and/or
manufacturer authorized distribution networks for defined geographies.

Which supplier categories matter operationally?

Manufacturer/labeler (sells to distribution chain)
National wholesaler (delivers to hospitals)
Regional/alternate channel distributor (fills local inventory gaps)
GPO contract supplier (controls price and availability for many systems)

How do you identify the correct supplier using the NDC for Marcaine Hydrochloride Preservative Free?

Answer: Supplier identity is best confirmed by the NDC and labeler/manufacturer code for the exact presentation (strength and container type).

What procurement fields should match before issuing a purchase order?

NDC
strength (mg/mL)
pack size
container type (vial size)
labeler (as shown on packaging)
manufacturer (as shown on packaging)
expiration date and lot number requirements

Why NDC-level verification changes “who the supplier is”

The same INN name (bupivacaine hydrochloride) can appear with:

different labelers,
reformulated presentations,
contract-specific relabeling,
packaging differences.

Procurement teams often lock to an NDC to avoid substituting a different manufacturer presentation.

What generic or equivalent bupivacaine hydrochloride suppliers can substitute for Marcaine Hydrochloride Preservative Free?

Answer: Substitution risk is determined by whether an equivalent bupivacaine hydrochloride injection, preservative free product exists in the same strength and container configuration under GPO contracts.

Typical substitution structure

Branded Marcaine presentation remains preferred when available under contract.
When constrained, health systems shift to other preservative-free bupivacaine hydrochloride injectable products marketed by different manufacturers.

What to verify for substitution

preservative-free specification
NDC match on pharmacy formulary
intended administration method compatibility (local infiltration, epidural, nerve block, catheter)

What Orange Book status matters for supplier selection of Marcaine Hydrochloride Preservative Free?

No supplier selection can be reliably tied to exclusivity or patent status without the specific NDC-level product identification and its FDA reference listed drug (RLD) mapping.

What you normally check in Orange Book

RLD name and strength
patent numbers and expiration dates
exclusivity periods (if applicable)
whether the listed patents cover formulation, method of use, or manufacturing

What patent estate affects how many suppliers carry bupivacaine preservative-free injection?

Supplier count is usually constrained by:

whether the branded product is protected by listed patents at the NDA/RLD level,
whether generics can enter via Paragraph IV or other permitted routes.

Without the specific RLD mapping for the exact Marcaine presentation, the patent estate cannot be stated accurately for this product name alone.

Which contract and purchasing channels determine who can supply hospitals?

Answer: For US hospitals, the practical supplier list is shaped by:

GPO access
wholesaler stocking policies
formulary approvals and therapeutic interchange rules
tendering schedules

GPO and wholesaler impact

Even when multiple manufacturers exist, the hospital may receive product only from:

the contracted national wholesaler
contracted supply brands under its GPO agreement

What generic entry risks exist for preservative-free bupivacaine injection?

Answer: Generic entry risk depends on whether the equivalent product is protected by:

listed patents at RLD level
formulation or manufacturing patents specific to preservative-free presentation
regulatory barriers such as product-specific chemistry, sterility requirements, and container/closure validation

A precise risk assessment requires the exact FDA RLD and NDC mapping.

How does Marcaine Hydrochloride Preservative Free supply compare with other bupivacaine injection strengths and preservatives?

Answer: The “preservative free” attribute usually narrows the supplier set compared with standard bupivacaine hydrochloride injection that may contain preservatives. Supplier availability therefore depends on:

whether the manufacturer produces preservative-free vials at the required strength and pack
whether the product is actively stocked by the hospital’s wholesaler

Key Takeaways

Supplier flow for Marcaine Hydrochloride Preservative Free in the US typically runs from the manufacturer/labeler through major wholesalers such as McKesson, Cardinal Health, and Cencora to hospitals and surgery centers.
Supplier identification in procurement should be anchored to the exact NDC for the specific strength and vial configuration labeled “preservative free.”
Substitution to equivalent preservative-free bupivacaine hydrochloride injection can occur when branded inventory is constrained, but substitution should be verified at the NDC and preservative-free specification level.
Patent and Orange Book-driven supplier diversity cannot be mapped without the specific FDA RLD/NDC for the exact Marcaine presentation.

FAQs

How do I confirm the manufacturer for Marcaine Hydrochloride Preservative Free for a purchase order?
Use the exact NDC on the label and match the labeler/manufacturer fields.
Which wholesalers typically stock Marcaine Hydrochloride Preservative Free for US hospitals?
Commonly McKesson, Cardinal Health, and Cencora.
Can I substitute a different bupivacaine hydrochloride injection if the system runs out of preservative-free Marcaine?
Only if the substitute is preservative free, matches the strength and container configuration, and is acceptable under formulary and interchange rules.
What document set should suppliers provide for sterile preservative-free injectables?
Lot-level CoA, sterility-related documentation, and compliance with storage/handling requirements.
Does “preservative free” change supplier eligibility compared with standard bupivacaine?
Yes. “Preservative free” often reduces the number of equivalent SKUs available through a given contract and wholesaler stocking plan.

References (APA)

U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
FDA. Drug labeling and NDC directory resources (for labeler/manufacturer identification). https://www.fda.gov

Suppliers and packagers for MARCAINE HYDROCHLORIDE PRESERVATIVE FREE