NDC Code(s) : 51655-152-52
Packager : Northwind Pharmaceuticals, LLC

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:51655-152(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:51655-152-5230 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/03/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075964 03/31/2023

LABELER - Northwind Pharmaceuticals, LLC(036986393)

REGISTRANT - Northwind Pharmaceuticals, LLC(036986393)

Establishment
Name Address ID/FEI Business Operations
EPM Packaging 079124340 repack(51655-152)

PRINCIPAL DISPLAY PANEL

NDC: 51655-152-52

51655-152-52