na?
Store Makena at room temperature (59° to 86°F or 15° to 30°C)
Store Makena in the original box to protect it from light
Store the Makena box upright
Makena should be used within 5 weeks after first use.
Keep Makena out of the reach of children
General information about the safe and effective use of Makena.
Medicines are sometimes prescribed for purposes other than those mentioned in the Patient Information Leaflets. Do not take Makena for conditions for which it was not prescribed. Do not give Makena to other people, even if they have the same condition you have. It may harm them.
This leaflet summarizes the most important information about Makena. If you would like more information, talk with your healthcare provider. You can ask for information about Makena that is written for healthcare professionals.
For more information, go to www.makena.com or call Ther-Rx Corporation Customer Service at the toll free number 1-877-567-7676.
To refill a prescription or to check on prescription status, call the Makena Care Connection at the toll free number 1-800-847-3418.
What are the ingredients in Makena?
Active ingredient: hydroxyprogesterone caproate
Inactive ingredients: castor oil, benzyl benzoate, and benzyl alcohol (a preservative)
Manufactured by:
Baxter Pharmaceutical Solutions LLC
Bloomington, IN 47403
Marketed by:
Ther-Rx Corporation
St. Louis, MO 63044
P10059-1
3-1214-303
2/2011
PRINCIPAL DISPLAY PANEL
NDC 64011-243-01
MakenaTM
hydroxyprogesterone caproate injection
1250 mg/5 mL
(250 mg/mL)
FOR INTRAMUSCULAR USE
5 mL multidose vial
Rx ONLY
MAKENA
hydroxyprogesterone caproate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 64011-243
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydroxyprogesterone Caproate(Hydroxyprogesterone Caproate) Hydroxyprogesterone Caproate 250mg in1mL
Inactive Ingredients
Ingredient Name Strength
CASTOR OIL 277.8mg in1mL
BENZYL BENZOATE 514.3mg in1mL
BENZYL ALCOHOL 21.92mg in1mL
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 64011-243-01 5mLIn1VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021945 02/03/2011
Labeler -Ther-Rx Corporation(055041706)
Registrant -KV Pharmaceutical Co. (006291405)
Establishment
Name Address ID/FEI Operations
Baxter Pharmaceutical Solutions, LLC 604719430 manufacture,analysis
