NDC Code(s) : 57664-377-08, 57664-377-13, 57664-377-18
Packager : Sun Pharmaceutical Industries, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

tramadol hydrochloridetramadol hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-377
Route of Administration ORAL DEA Schedule CIV
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
STARCH, CORN(UNII: O8232NY3SJ)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white (white) Score no score
Shape CAPSULE Size 13 mm
Flavor Imprint Code 377
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57664-377-08100 in 1 BOTTLE Type 0: Not a Combination Product22/06/2002
2NDC:57664-377-13500 in 1 BOTTLE Type 0: Not a Combination Product22/06/2002
3NDC:57664-377-181000 in 1 BOTTLE Type 0: Not a Combination Product22/06/2002
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075964 06/22/2002

LABELER - Sun Pharmaceutical Industries, Inc.(146974886)

Establishment
Name Address ID/FEI Business Operations
Sun Pharmaceutical Industries Limited 650445203 manufacture(57664-377)

PRINCIPAL DISPLAY PANEL

50mg-100 Tablets

50