NDC Code(s) : 62756-130-02, 62756-130-01, 62756-131-02, 62756-131-01, 62756-240-64, 62756-240-83, 62756-356-64, 62756-356-83, 62756-356-66
Packager : Sun Pharmaceutical Industries, Inc.

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ondansetron hydrochloride ondansetron hydrochloride TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:62756-130
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ONDANSETRON HYDROCHLORIDE(UNII: NMH84OZK2B)
(ONDANSETRON - UNII:4AF302ESOS) 		ONDANSETRON4 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 10 mm
Flavor Imprint Code 130
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62756-130-0210 in 1 DOSE PACK 25/06/2007
110 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:62756-130-0130 in 1 BOTTLE Type 0: Not a Combination Product25/06/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077050 06/25/2007
ondansetron hydrochloride ondansetron hydrochloride TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:62756-131
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ONDANSETRON HYDROCHLORIDE(UNII: NMH84OZK2B)
(ONDANSETRON - UNII:4AF302ESOS) 		ONDANSETRON8 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 13 mm
Flavor Imprint Code 131
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62756-131-0210 in 1 DOSE PACK 25/06/2007
110 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:62756-131-0130 in 1 BOTTLE Type 0: Not a Combination Product25/06/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077050 06/25/2007
ondansetron ondansetron TABLET, ORALLY DISINTEGRATING
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:62756-240
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ONDANSETRON(UNII: 4AF302ESOS)
(ONDANSETRON - UNII:4AF302ESOS) 		ONDANSETRON4 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
GLYCERYL DISTEARATE(UNII: 73071MW2KM)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE (white to off white) Score no score
Shape OVAL Size 10 mm
Flavor STRAWBERRY Imprint Code 240
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62756-240-643 in 1 DOSE PACK 08/02/2007
110 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:62756-240-8330 in 1 BOTTLE Type 0: Not a Combination Product08/02/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077557 08/02/2007
ondansetron ondansetron TABLET, ORALLY DISINTEGRATING
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:62756-356
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ONDANSETRON(UNII: 4AF302ESOS)
(ONDANSETRON - UNII:4AF302ESOS) 		ONDANSETRON8 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
GLYCERYL DISTEARATE(UNII: 73071MW2KM)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE (white to off white) Score no score
Shape OVAL Size 13 mm
Flavor STRAWBERRY Imprint Code 241
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62756-356-643 in 1 DOSE PACK 08/02/2007
110 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:62756-356-8330 in 1 BOTTLE Type 0: Not a Combination Product08/02/2007
3NDC:62756-356-661 in 1 DOSE PACK 08/02/2007
310 in 1 BLISTER PACK Type 0: Not a Combination Product08/02/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077557 08/02/2007

LABELER - Sun Pharmaceutical Industries, Inc.(146974886)

Establishment
Name Address ID/FEI Business Operations
Sun Pharmaceutical Industries Limited 725959238 ANALYSIS(62756-130, 62756-131, 62756-240, 62756-356), MANUFACTURE(62756-130, 62756-131, 62756-240, 62756-356)

PRINCIPAL DISPLAY PANEL



NDC 62756-130-01
Ondansetron Hydrochloride Tablets

4 mg*
Rx only
30 Tablets
SUN PHARMA
spl-ondansetron-hcl-label-4mg

NDC 62756-131-01
Ondansetron Hydrochloride Tablets
8 mg*
Rx only
30 Tablets
SUN PHARMA

spl-ondansetron-hcl-label-4mg

NDC 62756-130-02
Ondansetron Hydrochloride Tablets
4 mg
Rx only
100 (10x10) Unit Dose Tablets
UNIT DOSE

SUN PHARMA
spl-ondansetron-hcl-label-4mg
NDC 62756-131-02
Ondansetron Hydrochloride Tablets
8 mg
Rx only
100 (10x10) Unit Dose Tablets
UNIT DOSE
SUN PHARMA

spl-ondansetron-hcl-label-4mg

PRINCIPAL DISPLAY PANEL




NDC 62756-240-83
Ondansetron Orally Disintegrating Tablets
4 mg
Rx only
30 Tablets
SUN PHARMA

spl-ondansetron-odt-label-4mg

NDC 62756-356-83
Ondansetron Orally Disintegrating Tablets
8 mg
Rx only
30 Tablets
SUN PHARMA

spl-ondansetron-odt-label-4mg

NDC 62756-240-64

Ondansetron Orally Disintegrating Tablets

4 mg

Rx only

30 Tablets

(3 blistercards each containing 10 tablets)
SUN PHARMA
spl-ondansetron-odt-label-4mg

NDC 62756-356-64
 Ondansetron Orally Disintegrating Tablets
 8 mg
 Rx only
 30 Tablets
 (3 blistercards each containing 10 tablets)
 SUN PHARMA

spl-ondansetron-odt-label-4mg