Ondansetron Hydrochloride (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 4 mg 30 bottle count

Representative sample of labeling (see the HOW SUPPLIED section for complete listing):

PRINCIPAL DISPLAY PANEL4 mg BOTTLE LABEL

APOTEX CORP. NDC 60505-1311-3

ONDANSETRON HYDROCHLORIDE TABLETS, USP

4 mg

Rx Only

30 Tablets

display panel 4 mg 30s
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 8 mg 30 bottle count

Representative sample of labeling (see the HOW SUPPLIED section for complete listing):

PRINCIPAL DISPLAY PANEL8 mg BOTTLE LABEL

APOTEX CORP. NDC 60505-1312-3

ONDANSETRON HYDROCHLORIDE TABLETS, USP

8 mg

Rx Only

30 Tablets

display panel 8 mg 30s
(click image for full-size original)
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-1311
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
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSE 2910 (15000 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOLS
POVIDONES
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 9mm
Flavor Imprint Code APO;OND4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-1311-3 30 TABLET in 1 BOTTLE None
2 NDC:60505-1311-4 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 3 TABLET in 1 BLISTER PACK This package is contained within the CARTON (60505-1311-4)
3 NDC:60505-1311-1 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (60505-1311-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077306 11/11/2008
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-1312
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
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSE 2910 (15000 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOLS
FERRIC OXIDE YELLOW
POVIDONES
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 10mm
Flavor Imprint Code APO;OND8
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-1312-3 30 TABLET in 1 BOTTLE None
2 NDC:60505-1312-4 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 3 TABLET in 1 BLISTER PACK This package is contained within the CARTON (60505-1312-4)
3 NDC:60505-1312-5 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (60505-1312-5)
4 NDC:60505-1312-1 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (60505-1312-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077306 11/11/2008
Labeler — Apotex Corp. (845263701)
Establishment
Name Address ID/FEI Operations
Apotex Inc. 205576023 analysis (60505-1311), analysis (60505-1312), manufacture (60505-1311), manufacture (60505-1312)
Establishment
Name Address ID/FEI Operations
Apotex Inc. 243805095 analysis (60505-1311), analysis (60505-1312), manufacture (60505-1311), manufacture (60505-1312)

Revised: 12/2012 Apotex Corp.

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