NDC Code(s) : 0536-3587-01, 0536-3587-02, 0536-3587-06, 0536-3587-10
Packager : Rugby Laboratories Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IbuprofenIbuprofen TABLET, COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0536-3587
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN(UNII: WK2XYI10QM)
(IBUPROFEN - UNII:WK2XYI10QM) 		IBUPROFEN200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)
HYPROMELLOSES(UNII: 3NXW29V3WO)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
EGG PHOSPHOLIPIDS(UNII: 1Z74184RGV)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
POVIDONE K30(UNII: U725QWY32X)
STARCH, CORN(UNII: O8232NY3SJ)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
SODIUM STARCH GLYCOLATE TYPE A CORN(UNII: AG9B65PV6B)
stearic acid(UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code G2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0536-3587-01100 in 1 BOTTLE
2NDC:0536-3587-02250 in 1 BOTTLE
3NDC:0536-3587-0650 in 1 BOTTLE
4NDC:0536-3587-101000 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079174 03/01/2011

PRINCIPAL DISPLAY PANEL

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN NDC: 0536-3587-10

Non-Prescription Strength

Ibuprofen

Tablets USP, 200mg

Pain Reliever/Fever Reducer (NSAID)

1000 BROWN COATED TABLETS

IbuprofenIbuprofen