sion. The contents of one 10 mL vial (0.1 mg/mL) may be added to a 50 mL infusion bag to form an admixture of approximately 0.017 mg/mL ibutilide fumarate. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Compatibility and Stability
The following diluents are compatible with CORVERT Injection (0.1 mg/mL)
5% Dextrose Injection
0.9% Sodium Chloride Injection
The following intravenous solution containers are compatible with admixtures of CORVERT Injection (0.1 mg/mL):
polyvinyl chloride plastic bags
polyolefin bags
Admixtures of the product, with approved diluents, are chemically and physically stable for 24 hours at room temperature (15° to 30° C or 59° to 86° F) and for 48 hours at refrigerated temperatures (2° to 8°C or 36° to 46°F). Strict adherence to the use of aseptic technique during the preparation of the admixture is recommended in order to maintain sterility.
HOW SUPPLIED
CORVERT Injection (ibutilide fumarate injection) is supplied as an acetate-buffered isotonic solution at a concentration of 0.1 mg/mL that has been adjusted to approximately pH 4.6 in 10 mL clear glass, single-dose, flip-top vials.
Single-dose 10 mL vial, 1 mg /10 mL (0.1 mg/mL) NDC 0009-3794-01
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Store vial in carton until used.
SPL UNCLASSIFIED SECTION
Rx only
Logo
LAB-0129-3.0
August 2016
CLOSE
PRINCIPAL DISPLAY PANEL - 10 ML SINGLE-DOSE VIAL LABEL
NDC 0009-3794-01
10 mL Single-Dose Vial
Corvert®
(ibutilide fumarate injection)
1 mg/10 mL
(0.1 mg/mL)
For IV use only
Rx only
Pfizer Injectables
PRINCIPAL DISPLAY PANEL - 10 mL Single-Dose Vial Label
CLOSE
PRINCIPAL DISPLAY PANEL - 10 ML VIAL CARTON
NDC 0009-3794-01
10 mL Single-Dose Vial
Corvert®
(ibutilide fumarate
injection)
1 mg/10 mL
(0.1 mg/mL)
For intravenous use only
Rx only
Pfizer Injectables
PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton
CLOSE
INGREDIENTS AND APPEARANCE
CORVERT
ibutilide fumarate injection, solution
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0009-3794
Route of Administration INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
IBUTILIDE FUMARATE (UNII: 9L5X4M5L6I) (IBUTILIDE - UNII:2436VX1U9B) IBUTILIDE FUMARATE 0.1 mg in 1 mL
INACTIVE INGREDIENTS
Ingredient Name Strength
SODIUM ACETATE (UNII: 4550K0SC9B) 0.189 mg in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 8.9 mg in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0009-3794-01 1 in 1 CARTON 12/28/1995
1 10 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA
