Zaleplon (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Zaleplon Capsules USP 5 mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Zaleplon Capsules USP 10 mg
(click image for full-size original)
ZALEPLON zaleplon capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-131
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZALEPLON (ZALEPLON) ZALEPLON 5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 5
FERROSOFERRIC OXIDE
GELATIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SILICON DIOXIDE
SODIUM LAURYL SULFATE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (Light Blue) Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code U;131
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:29300-131-13 30 CAPSULE in 1 BOTTLE, PLASTIC None
2 NDC:29300-131-01 100 CAPSULE in 1 BOTTLE, PLASTIC None
3 NDC:29300-131-05 500 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078989 05/05/2009
ZALEPLON zaleplon capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-132
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZALEPLON (ZALEPLON) ZALEPLON 10 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
FD&C BLUE NO. 1
FD&C RED NO. 40
FERROSOFERRIC OXIDE
GELATIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SILICON DIOXIDE
SODIUM LAURYL SULFATE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (Dark Blue) Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code U;132
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:29300-132-01 100 CAPSULE in 1 BOTTLE, PLASTIC None
2 NDC:29300-132-05 500 CAPSULE in 1 BOTTLE, PLASTIC None
3 NDC:29300-132-10 1000 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078989 05/05/2009
Labeler — Unichem Pharmaceuticals (USA), Inc. (181620514)

Revised: 06/2021 Unichem Pharmaceuticals (USA), Inc.

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