L - 10 ML VIAL CARTON
NDC 0009-3794-22
Corvert®
Ibutilide
Fumarate Inj.
1 mg per
10 mL
(0.1 mg per mL)
10 mL Single Dose Vial
For Intravenous Use Only
Rx ONLY
NOVAPLUS®
PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton
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:0009-3794-22 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 NDA020491 12/28/1995
LABELER - PHARMACIA AND UPJOHN COMPANY LLC (618054084)
REGISTRANT - PFIZER INC (113480771)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Pharmacia and Upjohn Company LLC 618054084 ANALYSIS(0009-3794) , API MANUFACTURE(0009-3794) , MANUFACTURE(0009-3794)
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2428969a-7431-4e94-9503-ad5c680e2ea4 |
