NDC Code(s) : 60505-0171-1, 60505-0171-2, 60505-0171-8, 60505-0171-5
Packager : Apotex Corp.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE TABLET, COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-0171
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRAMADOL HYDROCHLORIDE(UNII: 9N7R477WCK)
(TRAMADOL - UNII:39J1LGJ30J) 		TRAMADOL HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)(UNII: 8136Y38GY5)
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 9 mm
Flavor Imprint Code APO;TR;50
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60505-0171-1100 in 1 BOTTLE Type 0: Not a Combination Product10/07/2002
2NDC:60505-0171-2500 in 1 BOTTLE Type 0: Not a Combination Product10/07/2002
3NDC:60505-0171-81000 in 1 BOTTLE Type 0: Not a Combination Product10/07/2002
4NDC:60505-0171-52700 in 1 BOTTLE Type 0: Not a Combination Product10/07/2002
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075981 07/10/2002 05/30/2016

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL - 50 mg BOTTLE LABEL

APOTEX CORP. NDC 60505-0171-1

Tramadol Hydrochloride Tablets, USP

50 mg

Rx Only

100 Tablets