Remdesivir

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Reconstitution and dilutionFull monograph review pending

U.S. label preparation

Veklury · Reconstitution and dilution

Preparation: For the 100 mg lyophilized vial, add 19 mL sterile water for injection (5 mg/mL). Further dilute with 0.9% sodium chloride.
Administration and handling: For adults and pediatric patients at least 40 kg, use the 100 or 250 mL preparation table. For pediatric patients 1.5 kg to under 40 kg, follow the 1.25 mg/mL instructions.

Product and source details

Gilead Sciences, Inc. · NDA214787

Product NDC: 61958-2901

SPL effective 2026-07-29 | SPL version 24. Checked 2026-11-13.

Source for this summary: U.S. prescribing information. Use the full label for dose selection, contraindications, preparation tables and monitoring.

Reviewed product information

Applies to

VEKLURY 100 mg lyophilized single-dose vial, Gilead; adult preparation only. Excludes the liquid presentation retained in older SPL product data.

Preparation sources checked 2026-11-13.

Reconstitution

For the 100 mg lyophilized vial, add 19 mL Sterile Water for Injection.

Sources and exact locations

Claim ID: IVR-REMDESIVIR-001

Review basis: Separately authored institutional guidance

Source 1
VEKLURY (remdesivir) injection and powder for injection (opens in a new tab)
Exact location: 2.5 Preparation and Administration; Reconstitution Instructions; section UUID b075f3e0-cbcf-4cdf-876b-edf10a13adaa
Publisher: National Library of Medicine / DailyMed; labeler-submitted U.S. SPL
Source family: U.S. product prescribing information
Retrieved: 2026-11-04T18:47:24.060516+00:00
A retrieved label is one evidence source. Downloading an XML file does not establish an independently corroborated clinical monograph or current availability of every listed presentation.
Source 2
Remdesivir intravenous infusion for adults (opens in a new tab)
Exact location: Reconstitution; first instruction for the Veklury 100 mg vial
Publisher: Galway University Hospitals / Medinfo Galway
Source family: Independent institutional administration guide (Ireland)
Retrieved: 2026-11-04T18:56:57.610191+00:00
Separately authored institutional guidance, partly based on product labeling. Used only for explicitly concordant preparation statements; Irish policy and formulation-specific differences are not transferred to U.S. products. Not independent primary trial evidence.

Reconstitution

The resulting reconstituted solution contains 5 mg/mL (100 mg in 20 mL).

Sources and exact locations

Claim ID: IVR-REMDESIVIR-002

Review basis: Separately authored institutional guidance

Source 1
VEKLURY (remdesivir) injection and powder for injection (opens in a new tab)
Exact location: 2.5; Reconstitution Instructions; final concentration paragraph; section UUID b075f3e0-cbcf-4cdf-876b-edf10a13adaa
Publisher: National Library of Medicine / DailyMed; labeler-submitted U.S. SPL
Source family: U.S. product prescribing information
Retrieved: 2026-11-04T18:47:24.060516+00:00
A retrieved label is one evidence source. Downloading an XML file does not establish an independently corroborated clinical monograph or current availability of every listed presentation.
Source 2
Remdesivir intravenous infusion for adults (opens in a new tab)
Exact location: Reconstitution; stated final concentration
Publisher: Galway University Hospitals / Medinfo Galway
Source family: Independent institutional administration guide (Ireland)
Retrieved: 2026-11-04T18:56:57.610191+00:00
Separately authored institutional guidance, partly based on product labeling. Used only for explicitly concordant preparation statements; Irish policy and formulation-specific differences are not transferred to U.S. products. Not independent primary trial evidence.

Dilution

Further dilute the reconstituted drug with 0.9% Sodium Chloride Injection before infusion.

Sources and exact locations

Claim ID: IVR-REMDESIVIR-003

Review basis: Separately authored institutional guidance

Source 1
VEKLURY (remdesivir) injection and powder for injection (opens in a new tab)
Exact location: 2.1 Dosage and Administration Overview; final bullet; 2.5 Dilution Instructions
Publisher: National Library of Medicine / DailyMed; labeler-submitted U.S. SPL
Source family: U.S. product prescribing information
Retrieved: 2026-11-04T18:47:24.060516+00:00
A retrieved label is one evidence source. Downloading an XML file does not establish an independently corroborated clinical monograph or current availability of every listed presentation.
Source 2
Remdesivir intravenous infusion for adults (opens in a new tab)
Exact location: Infusion fluids; and Reconstitution, further-dilution instruction
Publisher: Galway University Hospitals / Medinfo Galway
Source family: Independent institutional administration guide (Ireland)
Retrieved: 2026-11-04T18:56:57.610191+00:00
Separately authored institutional guidance, partly based on product labeling. Used only for explicitly concordant preparation statements; Irish policy and formulation-specific differences are not transferred to U.S. products. Not independent primary trial evidence.

Infusion

For the reviewed adult preparation, administer the diluted dose by IV infusion over 30 to 120 minutes.

Sources and exact locations

Claim ID: IVR-REMDESIVIR-004

Review basis: Separately authored institutional guidance

Source 1
VEKLURY (remdesivir) injection and powder for injection (opens in a new tab)
Exact location: 2.5 Administration Instructions for Adults and Pediatric Patients Weighing at Least 40 kg; section UUID bb45afbc-26f0-405f-8d53-ea1baf8f27ab
Publisher: National Library of Medicine / DailyMed; labeler-submitted U.S. SPL
Source family: U.S. product prescribing information
Retrieved: 2026-11-04T18:47:24.060516+00:00
A retrieved label is one evidence source. Downloading an XML file does not establish an independently corroborated clinical monograph or current availability of every listed presentation.
Source 2
Remdesivir intravenous infusion for adults (opens in a new tab)
Exact location: Methods of intravenous administration; infusion-time instruction and table
Publisher: Galway University Hospitals / Medinfo Galway
Source family: Independent institutional administration guide (Ireland)
Retrieved: 2026-11-04T18:56:57.610191+00:00
Separately authored institutional guidance, partly based on product labeling. Used only for explicitly concordant preparation statements; Irish policy and formulation-specific differences are not transferred to U.S. products. Not independent primary trial evidence.

Vial Inspection

Discard the vial if the vacuum fails to draw sterile water into it.

Sources and exact locations

Claim ID: IVR-71-VEKLURY-001

Review basis: Separately edited institutional reference

Source 1
VEKLURY (remdesivir) injection and powder for injection (opens in a new tab)
Exact location: U.S. prescribing information, section 2.5, Reconstitution Instructions
Publisher: National Library of Medicine / DailyMed; labeler-submitted U.S. SPL
Source family: U.S. product prescribing information
Retrieved: 2026-11-04T18:47:24.060516+00:00
A retrieved label is one evidence source. Downloading an XML file does not establish an independently corroborated clinical monograph or current availability of every listed presentation.
Source 2
Remdesivir intravenous infusion for adults (opens in a new tab)
Exact location: Reconstitution
Publisher: Galway University Hospitals Medicines Information
Source family: Galway University Hospitals
Retrieved: 2026-11-13

Reconstitution

After adding the sterile water, shake the vial for 30 seconds, then allow 2 to 3 minutes for settling.

Sources and exact locations

Claim ID: IVR-71-VEKLURY-002

Review basis: Separately edited institutional reference

Source 1
VEKLURY (remdesivir) injection and powder for injection (opens in a new tab)
Exact location: U.S. prescribing information, section 2.5, Reconstitution Instructions
Publisher: National Library of Medicine / DailyMed; labeler-submitted U.S. SPL
Source family: U.S. product prescribing information
Retrieved: 2026-11-04T18:47:24.060516+00:00
A retrieved label is one evidence source. Downloading an XML file does not establish an independently corroborated clinical monograph or current availability of every listed presentation.
Source 2
Remdesivir intravenous infusion for adults (opens in a new tab)
Exact location: Reconstitution
Publisher: Galway University Hospitals Medicines Information
Source family: Galway University Hospitals
Retrieved: 2026-11-13

Infusion Bag Preparation

After adding the prescribed reconstituted volume to the adult infusion bag, gently invert the bag 20 times. Avoid shaking the bag.

Sources and exact locations

Claim ID: IVR-71-VEKLURY-003

Review basis: Separately edited institutional reference

Source 1
VEKLURY (remdesivir) injection and powder for injection (opens in a new tab)
Exact location: U.S. prescribing information, section 2.5, Dilution Instructions
Publisher: National Library of Medicine / DailyMed; labeler-submitted U.S. SPL
Source family: U.S. product prescribing information
Retrieved: 2026-11-04T18:47:24.060516+00:00
A retrieved label is one evidence source. Downloading an XML file does not establish an independently corroborated clinical monograph or current availability of every listed presentation.
Source 2
Remdesivir intravenous infusion for adults (opens in a new tab)
Exact location: Methods of intravenous administration
Publisher: Galway University Hospitals Medicines Information
Source family: Galway University Hospitals
Retrieved: 2026-11-13

Product identifiers and clinical review status

U.S. label preparation available. Full monograph review pending.

Selected product identity

Matched U.S. label formulation for the limited claims; full monograph identity review remains incomplete.

View product identifiers and primary-label provenance

Selected product scope: VEKLURY 100 mg lyophilized single-dose vial, Gilead; adult preparation only. Excludes the liquid presentation retained in older SPL product data.
Field ID: IVR-REMDESIVIR-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: Gilead Sciences, Inc.
Field ID: IVR-REMDESIVIR-META-LABELER
Primary source (opens in a new tab) | SPL author/assignedEntity/representedOrganization/name
Complete product reconciliation: pending.
Application number(s): NDA214787
Field ID: IVR-REMDESIVIR-META-APPLICATION-NUMBERS
Primary source (opens in a new tab) | SPL subjectOf/approval/id/@extension
Complete product reconciliation: pending.
NDC(s): 61958-2901-2
Field ID: IVR-REMDESIVIR-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: c0978fa8-53ff-4ca2-82a7-567fd3e958ca
Field ID: IVR-REMDESIVIR-META-SETID
Primary source (opens in a new tab) | SPL document/setId/@root
Complete product reconciliation: pending.
SPL version: 24
Field ID: IVR-REMDESIVIR-META-SPL-VERSION
Primary source (opens in a new tab) | SPL document/versionNumber/@value
Complete product reconciliation: pending.
Label printed revision date: Not independently reconciled
Field ID: IVR-REMDESIVIR-META-LABEL-REVISION-DATE
Primary source (opens in a new tab) | Printed revision statement in the selected label; distinct from SPL effectiveTime
Complete product reconciliation: pending.
SPL effective date: 2026-07-29
Field ID: IVR-REMDESIVIR-META-REVISION-DATE
Primary source (opens in a new tab) | SPL document/effectiveTime/@value
Complete product reconciliation: pending.
Retrieved: 2026-11-04T18:47:24.060516+00:00
Field ID: IVR-REMDESIVIR-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: 1200ee513a4816f5ab4dc0cefea66a7a67f3a6e012cc9fe56175ce80f7d70bb6
Field ID: IVR-REMDESIVIR-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

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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