Itraconazole (Page 9 of 9)

PRINCIPAL DISPLAY PANEL – 100 mg

NDC 0378-5100-93

Itraconazole
Capsules, USP
100 mg

Rx only 30 Capsules

Each capsule contains:
Itraconazole, USP 100 mg

Usual Dosage: See accompanying
prescribing information.

Keep this and all medication out of
the reach of children.

Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]

Protect from light and moisture.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

RMX5100H5

Dispense in a tight, light-resistant
container as defined in the USPusing a child-resistant closure.

Keep container tightly closed.

Code No.: MH/DRUGS/25/NKD/89

Itraconazole Capsules, USP 100 mg Bottle Label
(click image for full-size original)
ITRACONAZOLE itraconazole capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-5100
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
FERROSOFERRIC OXIDE
FD&C BLUE NO. 2
GELATIN, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
FERRIC OXIDE RED
SHELLAC
SODIUM HYDROXIDE
STARCH, CORN
SUCROSE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color BLUE (dark blue opaque) , BROWN (caramel opaque) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code MYLAN;5100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-5100-93 30 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200463 07/26/2012
Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 09/2019 Mylan Pharmaceuticals Inc.

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