NDC Code(s) : 29300-355-01, 29300-355-05, 29300-355-10
Packager : Unichem Pharmaceuticals (USA), Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Tramadol HydrochlorideTramadol Hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-355
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
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color YELLOW (pale yellow) Score 2 pieces
Shape CAPSULE Size 13 mm
Flavor Imprint Code U;355
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:29300-355-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/04/2019
2NDC:29300-355-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/04/2019
3NDC:29300-355-101000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/04/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211825 08/09/2019

LABELER - Unichem Pharmaceuticals (USA), Inc.(181620514)

REGISTRANT - Unichem Laboratories Limited, India(650055882)

PRINCIPAL DISPLAY PANEL

Label