NDC Code(s) : 55289-719-10, 55289-719-12, 55289-719-15, 55289-719-20, 55289-719-30, 55289-719-40, 55289-719-50, 55289-719-60, 55289-719-90, 55289-719-98, 55289-719-94
Packager : PD-Rx Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Tramadol HydrochlorideTramadol Hydrochloride TABLET, COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55289-719(NDC:65162-627)
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
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYPROMELLOSES(UNII: 3NXW29V3WO)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color white Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code AN;627
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55289-719-1010 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/07/2014
2NDC:55289-719-1212 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/07/2014
3NDC:55289-719-1515 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/07/2014
4NDC:55289-719-2020 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/07/2014
5NDC:55289-719-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/07/2014
6NDC:55289-719-4040 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/07/2014
7NDC:55289-719-5050 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/07/2014
8NDC:55289-719-6060 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/07/2014
9NDC:55289-719-9090 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/07/2014
10NDC:55289-719-98120 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/07/2014
11NDC:55289-719-94270 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/09/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076003 11/15/2010

PRINCIPAL DISPLAY PANEL

Tramadol Hydrochloride Tablets USP, 50 mg

Rx only

55289719 Label