Raloxifene Hydrochloride (Page 9 of 9)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 60 mg (30 Tablets Bottle)

PRASCO
NDC 66993-661-30
Raloxifene Hydrochloride
Tablets, USP 60 mg
PHARMACIST: Dispense the Medication
Guide provided separately to each patient.
30 Tablets Rx only

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 60 mg (30 Tablets Bottle)
(click image for full-size original)
RALOXIFENE HYDROCHLORIDE raloxifene hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-661
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 (120 .MU.M)
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
POVIDONE K30
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape OVAL (Elliptical) Size 12mm
Flavor Imprint Code X;57
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66993-661-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:66993-661-02 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:66993-661-88 2000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204310 08/28/2015 07/31/2022
Labeler — Prasco Laboratories (065969375)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (66993-661), MANUFACTURE (66993-661)

Revised: 09/2020 Prasco Laboratories

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