Estradiol (Page 5 of 5)

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Estradiol Tablets USP 1mg
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Estradiol Tablets USP 1 mg

NDC 68788-8063

Estradiol

Tablets USP

1 mg

PHARMACIST: Dispense the accompanying

Patient Information Sheet to each patient.

Rx only

ESTRADIOL
estradiol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-8063(NDC:51862-333)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 1 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
FD&C BLUE NO. 1 ALUMINUM LAKE
D&C RED NO. 27 ALUMINUM LAKE
Product Characteristics
Color PURPLE (light purple) Score 2 pieces
Shape OVAL Size 9mm
Flavor Imprint Code 886;1;b
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-8063-3 30 TABLET in 1 BOTTLE None
2 NDC:68788-8063-6 60 TABLET in 1 BOTTLE None
3 NDC:68788-8063-9 90 TABLET in 1 BOTTLE None
4 NDC:68788-8063-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040197 08/16/2021
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK (68788-8063)

Revised: 05/2022 Preferred Pharmaceuticals Inc.

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