Raloxifene Hydrochloride (Page 9 of 9)

Package/Label Display Panel

Raloxifene Hydrochloride Tablets, USP

60 mg

30 Tablets

carton label
(click image for full-size original)
RALOXIFENE HYDROCHLORIDE raloxifene hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6902(NDC:43598-505)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Raloxifene hydrochloride (Raloxifene) Raloxifene hydrochloride 60 mg
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
crospovidone
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POVIDONE, UNSPECIFIED
TITANIUM DIOXIDE
Product Characteristics
Color white (off-white) Score no score
Shape OVAL (biconvex) Size 12mm
Flavor Imprint Code SG;306
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-6902-04 30 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0904-6902-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206384 10/12/2016
Labeler — Major Pharmaceuticals (191427277)

Revised: 12/2021 Major Pharmaceuticals

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