NDC Code(s) : 68001-246-16, 68001-246-17, 68001-246-04, 68001-247-16, 68001-247-01, 68001-247-17, 68001-247-55, 68001-247-04
Packager : BluePoint Laboratories

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

OndansetronOndansetron TABLET, ORALLY DISINTEGRATING
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-246
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)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
Product Characteristics
Color white Score no score
Shape ROUND Size 7 mm
Flavor STRAWBERRY Imprint Code G;4
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68001-246-1610 in 1 BLISTER PACK Type 0: Not a Combination Product13/03/2014
2NDC:68001-246-1730 in 1 BOX, UNIT-DOSE Type 0: Not a Combination Product13/03/2014
3NDC:68001-246-0430 in 1 BOTTLE Type 0: Not a Combination Product13/02/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078152 03/13/2014
OndansetronOndansetron TABLET, ORALLY DISINTEGRATING
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-247
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)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
Product Characteristics
Color white Score no score
Shape ROUND Size 8 mm
Flavor STRAWBERRY Imprint Code G;8
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68001-247-1610 in 1 BLISTER PACK Type 0: Not a Combination Product13/03/2014
2NDC:68001-247-0110 in 1 BOX, UNIT-DOSE Type 0: Not a Combination Product13/03/2014
3NDC:68001-247-1730 in 1 BOX, UNIT-DOSE Type 0: Not a Combination Product13/03/2014
4NDC:68001-247-5510 in 1 BOTTLE Type 0: Not a Combination Product13/02/2018
5NDC:68001-247-0430 in 1 BOTTLE Type 0: Not a Combination Product13/02/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078152 03/13/2014

LABELER - BluePoint Laboratories(985523874)

REGISTRANT - Glenmark Pharmaceuticals Inc(130597813)

Establishment
Name Address ID/FEI Business Operations
Glenmark Pharmaceuticals Limited 677318665 analysis(68001-246, 68001-247), manufacture(68001-246, 68001-247)

PRINCIPAL DISPLAY PANEL

Ondansetron Orally Disintegrating Tablets USP, 4 mg

NDC 68001-246-04, 30 Tablets

Ondasetron Orally Disintegrating Tablets USP 4mg

PRINCIPAL DISPLAY PANEL

Ondansetron Orally Disintegrating Tablets USP, 8 mg

NDC 68001-247-04, 30 Tablets

Ondasetron Orally Disintegrating Tablets

PRINCIPAL DISPLAY PANEL

Ondansetron Orally Disintegrating Tablets USP, 4 mg

NDC 68001-246-17, 30 Tablets

Ondansetron Orally Disintegrating Tablets

PRINCIPAL DISPLAY PANEL

Ondansetron Orally Disintegrating Tablets USP, 8 mg

NDC 68001-247-01, 30 Tablets

Ondansetron Orally Disintegrating Tablets