Last Updated: September 24, 2026

Suppliers and packagers for DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE


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DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Fresenius Kabi Usa DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE diphenhydramine hydrochloride INJECTABLE;INJECTION 091526 ANDA Fresenius Kabi USA, LLC 76045-102-10 24 BLISTER PACK in 1 CARTON (76045-102-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-102-00) / 1 mL in 1 SYRINGE, GLASS 2013-03-26
Fresenius Kabi Usa DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE diphenhydramine hydrochloride INJECTABLE;INJECTION 091526 ANDA Fresenius Kabi USA, LLC 76045-235-10 24 BLISTER PACK in 1 CARTON (76045-235-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-235-01) / 1 mL in 1 SYRINGE, GLASS 2025-06-02
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE

Last updated: April 25, 2026

Who Supplies “Diphenhydramine Hydrochloride Preservative Free”?

No supplier list can be produced from the information provided. The product description alone does not identify a specific dosage form (oral solution, injection, ophthalmic, topical), strength, package configuration, route of administration, or regulatory status (finished drug vs. API). Without those fields, any supplier set would be incomplete and unverifiable.

What can be identified from the name alone

“Diphenhydramine hydrochloride preservative free” can map to multiple distinct commercial products that use different manufacturing networks and different controlled specifications (sterile vs. non-sterile, single-dose vs. multi-dose, ophthalmic vs. systemic, etc.). Under standard procurement practice, suppliers are selected by exact market SKU and CMC scope, not by the active ingredient name alone.

Typical supplier categories (not vendor-specific)

Because supplier naming depends on the exact product form, the only actionable structure that can be stated without inventing vendor facts is the category breakdown used in pharma sourcing:

  1. API suppliers (diphenhydramine hydrochloride bulk)
  2. Finished-dose manufacturers for preservative-free drug products (drug product manufacturing, including sterile processing if applicable)
  3. CMO/CDMO sterile fill-finish providers (only if the product is an injectable or ophthalmic formulation)
  4. Relabelers/private label manufacturers (only if the product is sold under a distributor brand)

Data required to produce a real supplier map (what is missing)

A supplier list is only defensible when it ties to at least:

  • dosage form and route (e.g., injection vs. oral vs. ophthalmic)
  • strength (mg/mL, mg/5 mL, etc.)
  • unit type (single-dose vial, ampoule, syringe, bottle)
  • sterility class and container closure system (single-use, USP <797>/<800> expectations if sterile)
  • regional authorization (US, EU, other), and whether sourcing targets API or finished product

Key Takeaways

  • “Diphenhydramine hydrochloride preservative free” is not sufficient to generate a verified supplier roster.
  • Supplier selection for this drug depends on the exact dosage form, strength, and whether the product is sterile and filled in single-use or multi-dose presentations.

FAQs

  1. Are API suppliers the same as finished-dose suppliers for preservative-free diphenhydramine?
    No. API sourcing and drug product manufacturing are separate vendor pools with different qualification and regulatory pathways.

  2. Does “preservative free” always mean sterile?
    No. Preservative-free can apply to non-sterile oral formulations and sterile formulations. Sterility depends on route and product design.

  3. How do purchasing teams identify the correct supplier shortlist for this product?
    They map by exact SKU attributes: dosage form, strength, container type, and whether the drug product is sterile and single-dose.

  4. Can a relabeler supply “preservative free” without making the product?
    Yes. Some companies distribute or repackage under a private label while the manufacturing is performed by a different entity.

  5. What is the minimum info needed to name suppliers accurately?
    An exact product specification that uniquely identifies the commercial form (route, dosage form, strength, and presentation) and whether the target is API or finished drug product.

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