Bivalirudin
Reconstitution and dilutionFull monograph review pending
U.S. label preparation
Avenacy bivalirudin 250 mg lyophilized vial · Reconstitution and dilution
- Preparation
- Add 5 mL sterile water for injection to the vial and swirl gently. Remove 5 mL from a 50 mL bag of 0.9% sodium chloride or 5% dextrose. Add the full reconstituted vial to make 5 mg/mL.
- Administration and handling
- Use this diluted solution for the prescribed IV bolus and infusion.
Product and source details
Avenacy, LLC · ANDA210031
Product NDC: 83634-400
SPL effective 2026-08-20 | SPL version 2. 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
Avenacy bivalirudin 250 mg lyophilized vial, adult IV preparation.
The hospital guide addresses a different clinical indication. Its preparation method corroborates the vial and bag steps only.
Preparation sources checked 2026-11-13.
Reconstitution
Swirl the 250 mg vial gently with 5 mL sterile water for injection until the powder dissolves.
Sources and exact locations
Claim ID: IVR-70-BIVALIRUDIN-001
Review basis: Separately authored institutional guidance
Source 1
Avenacy bivalirudin 250 mg lyophilized vial U.S. prescribing information (opens in a new tab)
Exact location: 2.3
Publisher: Avenacy, LLC / DailyMed
Source family: U.S. product labeling 42aa2630-83d6-433d-8277-0f672cf8d71d
Retrieved: 2026-11-13
Source 2
Galway adult IV guide: Bivalirudin (opens in a new tab)
Exact location: Reconstitution
Publisher: Galway University Hospitals Medicines Information
Source family: Galway University Hospitals Medicines Information
Retrieved: 2026-11-13T14:26:25.272703+00:00
Separately edited hospital guidance may draw on product labeling. Only overlapping preparation steps are used.
Dilution
For a final volume of 50 mL, remove 5 mL from a 50 mL bag of 0.9% sodium chloride or 5% dextrose, then add all 5 mL of reconstituted drug. The diluted concentration is 5 mg/mL.
Sources and exact locations
Claim ID: IVR-70-BIVALIRUDIN-002
Review basis: Separately authored institutional guidance
Source 1
Avenacy bivalirudin 250 mg lyophilized vial U.S. prescribing information (opens in a new tab)
Exact location: 2.3
Publisher: Avenacy, LLC / DailyMed
Source family: U.S. product labeling 42aa2630-83d6-433d-8277-0f672cf8d71d
Retrieved: 2026-11-13
Source 2
Galway adult IV guide: Bivalirudin (opens in a new tab)
Exact location: Reconstitution and Infusion fluids
Publisher: Galway University Hospitals Medicines Information
Source family: Galway University Hospitals Medicines Information
Retrieved: 2026-11-13T14:26:25.272703+00:00
Separately edited hospital guidance may draw on product labeling. Only overlapping preparation steps are used.
Administration
Use the diluted 5 mg/mL preparation for both the prescribed IV bolus and the continuous infusion.
Sources and exact locations
Claim ID: IVR-70-BIVALIRUDIN-003
Review basis: Separately authored institutional guidance
Source 1
Avenacy bivalirudin 250 mg lyophilized vial U.S. prescribing information (opens in a new tab)
Exact location: 2.3
Publisher: Avenacy, LLC / DailyMed
Source family: U.S. product labeling 42aa2630-83d6-433d-8277-0f672cf8d71d
Retrieved: 2026-11-13
Source 2
Galway adult IV guide: Bivalirudin (opens in a new tab)
Exact location: Reconstitution, final dilution paragraph
Publisher: Galway University Hospitals Medicines Information
Source family: Galway University Hospitals Medicines Information
Retrieved: 2026-11-13T14:26:25.272703+00:00
Separately edited hospital guidance may draw on product labeling. Only overlapping preparation steps are used.
Product identifiers and clinical review status
U.S. label preparation available. Full monograph review pending.
Selected product identity
Matched to the selected IV presentation.
View product identifiers and primary-label provenance
- Selected product scope
- Avenacy bivalirudin 250 mg lyophilized vial, adult IV preparation.
- Labeler
- Avenacy, LLC
- Application number(s)
- ANDA210031
- NDC(s)
- 83634-400
- DailyMed Set ID
- 42aa2630-83d6-433d-8277-0f672cf8d71d
- SPL version
- 2
- Label printed revision date
- Not established
- SPL effective date
- 2026-08-20
- Retrieved
- 2026-11-13
- Downloaded XML SHA-256
- 5f42e16a75d4e1adcb38015a950bb36a735283b33fdca16e623c8e8eeae4cb21
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.