ZALEPLON (Page 8 of 8)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg (100 Capsules Bottle)

NDC 65862-214-01
Rx only
Zaleplon Capsules USP
5 mg CIV
PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY
AUROBINDO 100 Capsules


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 5 mg (100 Capsules Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg (100 Capsules Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg (100 Capsules Bottle)

NDC 65862-215-01
Rx only
Zaleplon Capsules USP
10 mg CIV
PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELYAUROBINDO 100 Capsules

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 10 mg (100 Capsules Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg (100 Capsules Bottle)
ZALEPLON zaleplon capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-214
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
MICROCRYSTALLINE CELLULOSE
LACTOSE MONOHYDRATE
STARCH, CORN
SODIUM LAURYL SULFATE
SILICON DIOXIDE
STEARIC ACID
FD&C BLUE NO. 1
FD&C GREEN NO. 3
FD&C YELLOW NO. 5
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
FERROSOFERRIC OXIDE
SHELLAC
Product Characteristics
Color GREEN (Opaque Green or Opaque Pale Green) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code E19;5;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-214-01 100 CAPSULE in 1 BOTTLE None
2 NDC:65862-214-05 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078829 06/06/2008
ZALEPLON zaleplon capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-215
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
MICROCRYSTALLINE CELLULOSE
LACTOSE MONOHYDRATE
STARCH, CORN
SODIUM LAURYL SULFATE
SILICON DIOXIDE
STEARIC ACID
FD&C BLUE NO. 1
FD&C GREEN NO. 3
FD&C YELLOW NO. 5
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
FERROSOFERRIC OXIDE
SHELLAC
Product Characteristics
Color GREEN (Opaque Green or Opaque Light Green) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code E20;10;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-215-01 100 CAPSULE in 1 BOTTLE None
2 NDC:65862-215-05 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078829 06/06/2008
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917642 ANALYSIS (65862-214), ANALYSIS (65862-215), MANUFACTURE (65862-214), MANUFACTURE (65862-215)

Revised: 12/2021 Aurobindo Pharma Limited

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