Last Updated: June 9, 2026

Suppliers and packagers for etomidate


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etomidate

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Caplin ETOMIDATE etomidate INJECTABLE;INJECTION 215028 ANDA Caplin Steriles Limited 65145-127-10 10 VIAL, SINGLE-DOSE in 1 CARTON (65145-127-10) / 10 mL in 1 VIAL, SINGLE-DOSE (65145-127-01) 2026-02-05
Caplin ETOMIDATE etomidate INJECTABLE;INJECTION 215028 ANDA Caplin Steriles Limited 65145-128-10 10 VIAL, SINGLE-DOSE in 1 CARTON (65145-128-10) / 20 mL in 1 VIAL, SINGLE-DOSE (65145-128-01) 2026-02-05
Caplin ETOMIDATE etomidate INJECTABLE;INJECTION 215028 ANDA Fresenius Kabi USA, LLC 65219-445-10 10 VIAL, SINGLE-DOSE in 1 CARTON (65219-445-10) / 10 mL in 1 VIAL, SINGLE-DOSE (65219-445-01) 2021-08-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for etomidate

Last updated: May 24, 2026

Etomidate Drug Suppliers: Who Manufactures It, Who Supplies It, and What Contracts Shape Availability

Etomidate (an injectable anesthetic; active ingredient: etomidate) is typically supplied for hospitals through a mix of branded wholesalers and generic manufacturers. However, a complete, decision-grade supplier map (maker/labeler list by geography, unit strengths, NDCs, contract-packagers, and current procurement status) requires drug-specific sourcing records (FDA Orange Book/NDAs for labeler, NDC Directory for firms and package sizes, and commercial supply-chain listings by country). The information provided here is not sufficient to produce an accurate supplier roster for etomidate.

Who supplies etomidate injection in the US market?

No actionable supplier list can be produced from the available inputs because etomidate supply depends on the specific marketed product configuration (strength, package size, NDC) and the registered labeler/manufacturer for that NDC.

What NDC-level details determine etomidate “suppliers”?

Supplier responsibility in procurement is usually tied to:

  • NDC labeler (marketing authorization holder)
  • manufacturing site(s) (NDC manufacturer/label claim holder)
  • wholesaler distribution coverage (GPO/contracting)
  • product status (active, discontinued, temporarily unavailable)

Without NDC-to-firm mapping for etomidate, a “who supplies” answer would be incomplete and therefore not decision-grade.

Which companies manufacture etomidate API and which make the finished injection?

A correct answer requires a split by:

  • API suppliers (chemical/manufacturing source for etomidate bulk)
  • finished dosage form manufacturers (sterile injectable production)
  • contract manufacturers for sterile fill-finish

No API supplier or finished-dose manufacturer attribution can be stated accurately without sourcing documents that enumerate firms by product code and manufacturing site.

What are etomidate supplier risks for shortages and hospital procurement?

Supplier risk is driven by:

  • concentration of sterile fill-finish capacity for the relevant concentration and container closure
  • regulatory actions and manufacturing holds
  • batch release delays
  • raw material lead times for etomidate

A shortage-risk ranking needs current supply/discontinuation signals tied to the specific marketed etomidate NDC(s).

How do US FDA drug listings identify etomidate suppliers (Orange Book and NDC Directory)?

Orange Book is not typically used for excipients, and supplier identification depends on:

  • whether etomidate is listed as an approved drug product under an NDA
  • whether it appears under a corresponding ANDA
  • NDC Directory fields that map labelers to manufacturers

No NDA/ANDA identifiers or NDC data were provided, so supplier identification cannot be completed.

Which etomidate suppliers distribute through GPO contracts and group purchasing organizations?

GPO and major wholesaler contracting can differ from the actual manufacturer/labeler. A “contracted supplier” list must be built from:

  • GPO product masters by NDC
  • payer/hospital formulary entries
  • wholesaler allocation/distribution status

No contract master data was provided.

How does etomidate supply differ by country (EU, UK, Canada, Australia)?

Etomidate product availability varies by:

  • local marketing authorizations
  • labelling and packaging standards
  • sterile manufacturing approvals

A cross-region supplier roster requires country-specific marketing authorization and NDC equivalents.

What does etomidate patent status have to do with supplier availability?

In general, supply expansion from multiple manufacturers can follow:

  • generic approvals
  • ANDA or 505(b)(2) pathway entries
  • exclusivity periods
  • patent expirations or section viii carveouts

A supplier landscape cannot be linked to exclusivity or patent entry without a patent estate and regulatory approval timeline.

Which etomidate generic entry scenarios change the supplier list?

Supplier count typically increases when:

  • multiple ANDAs launch the same strength and package configuration
  • supply disruptions force wholesalers to substitute compliant SKUs

No ANDA launch data or NDC match set is provided.

Key Takeaways

  • A decision-grade supplier roster for etomidate requires NDC-level labeler/manufacturer mapping and, ideally, API and sterile fill-finish attribution.
  • The information available here does not include the product identifiers needed to enumerate etomidate suppliers accurately.
  • Etomidate supply should be assessed by NDC, strength, package size, and manufacturing site, not by the active ingredient alone.

FAQs

  1. How do I identify the correct etomidate supplier for a specific hospital purchase order?
    Use the exact NDC (strength and package size) tied to the order and match it to the NDC Directory labeler and manufacturer.

  2. Can different etomidate suppliers provide interchangeable products?
    Interchangeability depends on matching NDC, concentration, container closure, and sterility/labeling requirements.

  3. What supplier fields matter most for contracting and pharmacovigilance?
    Labeler, marketing authorization holder, and manufacturing site are the key fields used in batch traceability and adverse event reporting.

  4. Do etomidate shortages come from API or sterile fill-finish constraints?
    Shortages usually reflect sterile fill-finish capacity, batch release bottlenecks, or manufacturing holds more than API alone, but this must be verified for the relevant SKU.

  5. Does etomidate have multiple generic products with different suppliers?
    It can, but the supplier set must be confirmed at the NDC/SKU level for current availability.

References

  1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
  2. FDA. National Drug Code (NDC) Directory.

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