ntration of 0.1 mg/mL that has been adjusted to approximately pH 4.6 in 10 mL clear glass, single-dose, flip-top vials.
NDC 67457-366-10
carton containing single-dose 10 mL vial, 1 mg/10 mL (0.1 mg/mL).
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Store vial in carton until used.
Manufactured for:
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.
Manufactured by:
Gland Pharma Ltd
Hyderabad 500 043
India
Code No.: AP/DRUGS/103/97
REVISED OCTOBER 2012
MI:IBUTIJ:R2
LEA-019235-01
PRINCIPAL DISPLAY PANEL - 10 ML VIAL LABEL
NDC 67457-366-10 10 mL
Ibutilide
Fumarate
Injection
1 mg/10 mL
(0.1 mg/mL)
For Intravenous
Use Only
Rx only Single-Dose Vial
Sterile. Non-pyrogenic.
Each mL contains:
Ibutilide fumarate 0.1 mg,
sodium chloride 8.90 mg,
sodium acetate trihydrate
0.189 mg in water for
injection. When necessary,
pH was adjusted with
hydrochloric acid and/or
sodium hydroxide.
Usual Dosage: See
accompanying prescribing
information.
Store at 20° to 25°C
(68° to 77°F). [See USP
Controlled Room
Temperature.]
Store vial in carton until
used.
Manufactured for:
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.
Made in India
Code No.: AP/DRUGS/103/97
MI:366:1C:R3
Mylan.com
Ibutilide Fumarate Injection 1 mg/10 mL Carton Label
CLOSE
INGREDIENTS AND APPEARANCE
IBUTILIDE FUMARATE
ibutilide fumarate injection, solution
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-366
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 Chloride (UNII: 451W47IQ8X) 8.9 mg in 1 mL
Sodium Acetate (UNII: 4550K0SC9B) 0.189 mg in 1 mL
Water (UNII: 059QF0KO0R)
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Hydroxide (UNII: 55X04QC32I)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67457-366-10 1 in 1 CARTON
1 10 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090643 01/11/2010
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c25d21e7-6136-4a7a-b139-12f53116fc3d
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