Zaleplon (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OrchidPharma

NDC 42043-210-01

Zaleplon Capsules, USP

5 mg CIV

100 Capsules

Rx only

5mglabel
(click image for full-size original)

OrchidPharma

NDC 42043-211-01

Zaleplon Capsules, USP

10 mg CIV

100 Capsules

Rx only

10mglabel
(click image for full-size original)
ZALEPLON
zaleplon capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42043-210
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
LACTOSE MONOHYDRATE
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 5
Product Characteristics
Color GREEN (dark green) , blue (light blue) Score no score
Shape capsule Size 14mm
Flavor Imprint Code ZLP;2122
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42043-210-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090374 06/20/2018
ZALEPLON
zaleplon capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42043-211
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
LACTOSE MONOHYDRATE
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 5
Product Characteristics
Color GREEN (dark green) , blue (opaque blue) Score no score
Shape capsule Size 14mm
Flavor Imprint Code ZLP;2130
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42043-211-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090374 06/20/2018
Labeler — OrchidPharma Inc (809429207)
Registrant — Orchid Pharma Ltd (650133507)
Establishment
Name Address ID/FEI Operations
Orchid Healthcare (a division of Orchid Pharma Ltd) 650288850 analysis (42043-210), manufacture (42043-210), pack (42043-210), label (42043-210), analysis (42043-211), manufacture (42043-211), pack (42043-211), label (42043-211)

Revised: 01/2022 OrchidPharma Inc

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