Flumazenil

Limited reviewed summaryFull monograph review pending

No original GlobalRPh dilution article is available for this record.

Reviewed product information

Applies to

Henry Schein repackaged flumazenil injection 0.1 mg/mL for adult IV use. The preparation review covers the 5 mL vial.

The U.S. label distinguishes reversal of procedural sedation from overdose. Consult its boxed seizure warning and patient selection criteria. The Irish continuous-infusion regimen was excluded.

Preparation sources checked 2026-11-13.

Presentation

The 5 mL presentation contains 0.5 mg of flumazenil in solution (0.1 mg/mL).

Sources and exact locations

Claim ID: IVR-70-FLUMAZENIL-001

Review basis: Separately authored institutional guidance

Source 1
FLUMAZENIL U.S. prescribing information (opens in a new tab)
Exact location: DESCRIPTION (SPL section 50f0d101-8dcd-42d3-b459-d637bd300369); HOW SUPPLIED (SPL section ccf2aee6-76aa-427b-8687-fbac416210d0)
Publisher: DailyMed / Henry Schein, Inc.
Source family: U.S. product prescribing information
Retrieved: 2026-11-13T14:43:10.914215+00:00
Source 2
Galway adult IV guide: Flumazenil (opens in a new tab)
Exact location: Available preparations and Reconstitution
Publisher: Galway University Hospitals Medicines Information
Source family: Galway University Hospitals Medicines Information
Retrieved: 2026-11-13T14:43:11.118891+00:00
Separately edited hospital guidance may draw on product labeling. Only overlapping preparation steps are used.

Compatible Fluids

0.9% sodium chloride and 5% dextrose are compatible IV fluids.

Sources and exact locations

Claim ID: IVR-70-FLUMAZENIL-002

Review basis: Separately authored institutional guidance

Source 1
FLUMAZENIL U.S. prescribing information (opens in a new tab)
Exact location: DOSAGE AND ADMINISTRATION (SPL section 2a966a12-cb8d-4f03-ac8b-0c575daec344)
Publisher: DailyMed / Henry Schein, Inc.
Source family: U.S. product prescribing information
Retrieved: 2026-11-13T14:43:10.914215+00:00
Source 2
Galway adult IV guide: Flumazenil (opens in a new tab)
Exact location: Infusion fluids
Publisher: Galway University Hospitals Medicines Information
Source family: Galway University Hospitals Medicines Information
Retrieved: 2026-11-13T14:43:11.118891+00:00
Separately edited hospital guidance may draw on product labeling. Only overlapping preparation steps are used.

Product identifiers and clinical review status

Selected prescribing information available. Full monograph review pending.

Selected product identity

Matched to U.S. product NDC 0404-9793 for the preparation statements shown.

View product identifiers and primary-label provenance

Selected product scope: Henry Schein repackaged flumazenil injection 0.1 mg/mL for adult IV use. The preparation review covers the 5 mL vial.
Field ID: IVR-70-FLUMAZENIL-META-PRODUCT_SCOPE
Primary source (opens in a new tab) | Product data elements and the claim-specific formulation described in the cited preparation sections
Complete product reconciliation: pending.
Labeler: Henry Schein, Inc.
Field ID: IVR-70-FLUMAZENIL-META-LABELER
Primary source (opens in a new tab) | SPL author/assignedEntity/representedOrganization/name
Complete product reconciliation: pending.
Application number(s): ANDA078527
Field ID: IVR-70-FLUMAZENIL-META-APPLICATION_NUMBERS
Primary source (opens in a new tab) | SPL subjectOf/approval/id/@extension
Complete product reconciliation: pending.
NDC(s): 0404-9793-05
Field ID: IVR-70-FLUMAZENIL-META-NDCS
Primary source (opens in a new tab) | SPL manufacturedProduct/asContent/containerPackagedProduct/code/@code and How Supplied
Complete product reconciliation: pending.
DailyMed Set ID: 1855bb03-392f-4a0d-8361-24fc2a0e635e
Field ID: IVR-70-FLUMAZENIL-META-SETID
Primary source (opens in a new tab) | SPL document/setId/@root
Complete product reconciliation: pending.
SPL version: 2
Field ID: IVR-70-FLUMAZENIL-META-SPL_VERSION
Primary source (opens in a new tab) | SPL document/versionNumber/@value
Complete product reconciliation: pending.
Label printed revision date: Not established
SPL effective date: 2026-10-30
Field ID: IVR-70-FLUMAZENIL-META-REVISION_DATE
Primary source (opens in a new tab) | SPL document/effectiveTime/@value
Complete product reconciliation: pending.
Retrieved: 2026-11-13T14:43:10.914215+00:00
Field ID: IVR-70-FLUMAZENIL-META-RETRIEVED_AT
Primary source (opens in a new tab) | Timestamp recorded when source bytes were retrieved
Complete product reconciliation: pending.
Downloaded XML SHA-256: 258ef73392533fafeb318f34f717acb500bc363040ddac64595fcfc62936014c
Field ID: IVR-70-FLUMAZENIL-META-XML_SHA256
Primary source (opens in a new tab) | SHA-256 computed over the exact downloaded XML bytes
Complete product reconciliation: pending.

What remains to be completed

Extract and verify presentation-specific IV preparation.
Complete indication- and age-specific dosing, incompatibility, monitoring and stability review.
Assess any proposed compounding BUD for the exact formulation, concentration, container and conditions.

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