ZALEPLON (Page 8 of 8)

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

Rising^® NDC 57237-239-01
Zaleplon
Capsules USP CIV
5 mg
PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY
100 Capsules Rx only

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

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

Rising^® NDC 57237-240-01
Zaleplon
Capsules USP CIV
10 mg
PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY
100 Capsules Rx only

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

ZALEPLON zaleplon capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-239 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:57237-239-01 100 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:57237-240 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:57237-240-01 100 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 — Rising Health, LLC (080500961)

Registrant — Aurobindo Pharma Limited (650082092)

Establishment
Name	Address	ID/FEI	Operations
Aurobindo Pharma Limited		918917642	ANALYSIS (57237-239), ANALYSIS (57237-240), MANUFACTURE (57237-239), MANUFACTURE (57237-240)

Revised: 09/2019 Rising Health, LLC