Prempro (Page 11 of 11)

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Estrogens conjugated/Medroxyprogesterone 0.625/2.5mg tablet
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PREMPRO conjugated estrogens and medroxyprogesterone acetate tablet, sugar coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-1107(NDC:0046-1107)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTROGENS, CONJUGATED (ESTROGENS, CONJUGATED) ESTROGENS, CONJUGATED 0.625 mg
MEDROXYPROGESTERONE ACETATE (MEDROXYPROGESTERONE) MEDROXYPROGESTERONE ACETATE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
HYDROXYPROPYL CELLULOSE (1200000 MW)
SUCROSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POVIDONE, UNSPECIFIED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
TRIBASIC CALCIUM PHOSPHATE
HYPROMELLOSE 2208 (15000 MPA.S)
HYPROMELLOSE 2910 (15 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
Product Characteristics
Color ORANGE (PEACH) Score no score
Shape OVAL (OVAL) Size 10mm
Flavor Imprint Code PREMPRO;0625;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69189-1107-1 1 TABLET, SUGAR COATED in 1 DOSE PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020527 01/28/2016
Labeler — Avera McKennan Hospital (068647668)
Establishment
Name Address ID/FEI Operations
Avera McKennan Hospital 068647668 relabel (69189-1107), repack (69189-1107)

Revised: 03/2017 Avera McKennan Hospital

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