Danazol (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AvKARE
NDC 42291-243-01
DANAZOL Capsules USP
200 mg
100 Capsules Rx Only

Each capsule contains 200 mg danazol, USP.
Usual Dosage: See package insert for full prescribing information.
Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Keep out of the reach of children.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. A 01/12 AV 02/16 (P)

N3 42291 24301 9

label
(click image for full-size original)
DANAZOL danazol capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-243(NDC:0555-0635)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DANAZOL (DANAZOL) DANAZOL 200 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
D&C YELLOW NO. 10
ALUMINUM OXIDE
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SHELLAC
PROPYLENE GLYCOL
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
TITANIUM DIOXIDE
D&C RED NO. 28
Product Characteristics
Color orange Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code barr;635
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-243-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074582 02/23/2016
Labeler — AvKARE (796560394)

Revised: 01/2022 AvKARE

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