Raloxifene Hydrochloride (Page 9 of 9)

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

NDC 65862-709-30
Rx only
Raloxifene Hydrochloride
Tablets, USP
60 mg
PHARMACIST: Dispense the Medication Guide
provided separately to each patient.AUROBINDO 30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 60 mg (30 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 60 mg Blister Carton (3 x 10 Unit-dose)

NDC 65862-709-03 Rx only
Raloxifene Hydrochloride
Tablets, USP 60 mg
PHARMACIST: Dispense the Medication Guide provided separately to each patient. AUROBINDO 30 (3 x 10) Unit-dose Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 60 mg Blister Carton (3 x 10 Unit-dose)
(click image for full-size original)
RALOXIFENE HYDROCHLORIDE raloxifene hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-709
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:65862-709-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65862-709-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65862-709-22 2000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65862-709-03 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65862-709-10)
4 NDC:65862-709-10 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65862-709-03)
5 NDC:65862-709-99 1000 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
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (65862-709), MANUFACTURE (65862-709)

Revised: 02/2024 Aurobindo Pharma Limited

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