Itraconazole (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Itraconazole capsules USP 100 mg

Container label
(click image for full-size original)
ITRACONAZOLE itraconazole capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-463
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ITRACONAZOLE (ITRACONAZOLE) ITRACONAZOLE 100 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FERROSOFERRIC OXIDE
GELATIN
HYPROMELLOSE 2910 (5 MPA.S)
POLYETHYLENE GLYCOL 20000
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
STARCH, CORN
SUCROSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color blue (Blue opaque cap and pink transparent body) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code 100;1463
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-463-30 30 CAPSULE in 1 BOTTLE None
2 NDC:13668-463-05 500 CAPSULE in 1 BOTTLE None
3 NDC:13668-463-37 28 CAPSULE in 1 CARTON None
4 NDC:13668-463-90 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209460 08/24/2018
Labeler — Torrent Pharmaceuticals Limited (916488547)
Registrant — Torrent Pharma, Inc. (790033935)
Establishment
Name Address ID/FEI Operations
Torrent Pharmaceuticals Limited 916488547 manufacture (13668-463)

Revised: 03/2022 Torrent Pharmaceuticals Limited

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