Itraconazole (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Itraconazole Capsules, 100 mg

NDC 68382-697-06

30 Capsules

Zydus

Itraconazole Capsules
(click image for full-size original)
ITRACONAZOLE itraconazole capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-697
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
FD&C BLUE NO. 1
FD&C RED NO. 3
GELATIN
HYPROMELLOSE 2910 (5 MPA.S)
SODIUM LAURYL SULFATE
SUCROSE
TALC
TITANIUM DIOXIDE
BUTYL ALCOHOL
ALCOHOL
ISOPROPYL ALCOHOL
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
WATER
SHELLAC
AMMONIA
POLOXAMER 188
POLYETHYLENE GLYCOL 20000
Product Characteristics
Color BLUE (BLUE) Score no score
Shape CAPSULE (CAPSULE) Size 23mm
Flavor Imprint Code ZA;65;100;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-697-01 100 CAPSULE in 1 BOTTLE None
2 NDC:68382-697-10 1000 CAPSULE in 1 BOTTLE None
3 NDC:68382-697-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68382-697-30)
3 NDC:68382-697-30 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (68382-697-77)
4 NDC:68382-697-06 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204672 03/06/2018
Labeler — Zydus Pharmaceuticals USA Inc. (156861945)
Registrant — Zydus Pharmaceuticals USA Inc. (156861945)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 918596198 ANALYSIS (68382-697), MANUFACTURE (68382-697)

Revised: 11/2022 Zydus Pharmaceuticals USA Inc.

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