Medroxyprogesterone Acetate (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

Medroxyprogesterone 2.5 mg tablet
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MEDROXYPROGESTERONE ACETATE medroxyprogesterone acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-3740(NDC:59762-3740)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEDROXYPROGESTERONE ACETATE (MEDROXYPROGESTERONE) MEDROXYPROGESTERONE ACETATE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE
STARCH, CORN
LACTOSE, UNSPECIFIED FORM
MINERAL OIL
SORBIC ACID
SUCROSE
TALC
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code G3740
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69189-3740-1 1 TABLET in 1 DOSE PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA011839 02/02/2016
Labeler — Avera McKennan Hospital (068647668)
Establishment
Name Address ID/FEI Operations
Avera McKennan Hospital 068647668 relabel (69189-3740), repack (69189-3740)

Revised: 03/2017 Avera McKennan Hospital

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