Raloxifene Hydrochloride (Page 9 of 9)

PRINCIPAL DISPLAY PANEL

50268-694-15

Raloxifene HCl

Tablets, USP

60 mg

50 Tablets (5 X 10) Unit Dose

5026869415

50268-694-15

Raloxifene HCl

Tablets, USP

60 mg

50 Tablets (5 X 10) Unit Dose

5026869415

PHARMACIST: PLEASE DISPENSE THE MEDICATION GUIDE PROVIDED SEPARATELTY TO EACH PATIENT

Do not use if inner seal is missing or broken.

Each tablet contains Raloxifene HCI, USP ……60 mg

Usual Adult Dosage: See accompanying package literature.

Store at 20˚ to 25˚C (68˚ to 77˚F); excursions

permitted to 15˚ to 30˚C (59˚ to 86˚F) [see USP

Controlled Room Temperature].

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Manufactured for:

AvKARE, Inc.

Mfg. Rev. 04-2016-00 AV 06/18

Label 1
(click image for full-size original)
RALOXIFENE HYDROCHLORIDE raloxifene hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-694(NDC:65162-057)
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
POLYETHYLENE GLYCOL, UNSPECIFIED
ANHYDROUS LACTOSE
CROSPOVIDONE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
POVIDONE
SILICON DIOXIDE
TITANIUM DIOXIDE
Product Characteristics
Color white (off-white) Score no score
Shape OVAL Size 12mm
Flavor Imprint Code AN057
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-694-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (50268-694-11)
1 NDC:50268-694-11 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (50268-694-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208206 06/27/2018
Labeler — AvPAK (832926666)

Revised: 01/2022 AvPAK

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