ONDANSETRON HYDROCHLORIDE (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — Label — 4 mg


Ondansetron Hydrochloride Tablets
4 mg
30 TABLETS
Rx only
Rebel Distributors Corp

Ondansetron HCl 4mg
(click image for full-size original)
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-834(NDC:62756-130)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ONDANSETRON HYDROCHLORIDE (ONDANSETRON) ONDANSETRON 4 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
MAGNESIUM STEARATE
HYPROMELLOSES
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
Product Characteristics
Color white Score no score
Shape OVAL Size 10mm
Flavor Imprint Code 130
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-834-04 4 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:21695-834-12 12 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:21695-834-15 15 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
4 NDC:21695-834-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
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 Item Code (Source) NDC:21695-835(NDC:62756-131)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ONDANSETRON HYDROCHLORIDE (ONDANSETRON) ONDANSETRON 8 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
MAGNESIUM STEARATE
HYPROMELLOSES
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow Score no score
Shape OVAL Size 13mm
Flavor Imprint Code 131
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-835-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077050 06/25/2007
Labeler — Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 10/2010 Rebel Distributors Corp

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