NDC Code(s) : 63629-4022-1, 63629-4022-2, 63629-4306-1, 63629-4306-2, 63629-4306-3, 63629-4306-4, 63629-4306-5, 63629-4306-6, 63629-4306-7, 63629-4306-8, 63629-4306-9, 63629-4306-0
Packager : Bryant Ranch Prepack

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ondansetron hydrochlorideondansetron hydrochloride TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:63629-4022(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:63629-4022-130 in 1 BOTTLE Type 0: Not a Combination Product30/07/2009
2NDC:63629-4022-210 in 1 BOTTLE Type 0: Not a Combination Product30/07/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077050 06/25/2007 05/31/2019
ONDANSETRONondansetron TABLET, ORALLY DISINTEGRATING
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:63629-4306(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:63629-4306-130 in 1 BLISTER PACK Type 0: Not a Combination Product19/08/2013
2NDC:63629-4306-210 in 1 BLISTER PACK Type 0: Not a Combination Product19/08/2013
3NDC:63629-4306-35 in 1 BLISTER PACK Type 0: Not a Combination Product19/08/2013
4NDC:63629-4306-44 in 1 BLISTER PACK Type 0: Not a Combination Product20/08/2010
5NDC:63629-4306-56 in 1 BLISTER PACK Type 0: Not a Combination Product20/08/2010
6NDC:63629-4306-614 in 1 BLISTER PACK Type 0: Not a Combination Product20/08/2010
7NDC:63629-4306-760 in 1 BLISTER PACK Type 0: Not a Combination Product20/08/2010
8NDC:63629-4306-812 in 1 BLISTER PACK Type 0: Not a Combination Product20/08/2010
9NDC:63629-4306-990 in 1 BLISTER PACK Type 0: Not a Combination Product20/08/2010
10NDC:63629-4306-03 in 1 BLISTER PACK Type 0: Not a Combination Product20/08/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077557 08/02/2007

LABELER - Bryant Ranch Prepack(171714327)

Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(63629-4306, 63629-4022), RELABEL(63629-4022, 63629-4306)

PRINCIPAL DISPLAY PANEL

Label Image

PRINCIPAL DISPLAY PANEL

Label Image