Principal Display Panel

NDC 5960-580-50

Penn Pharmaceutical Services Ltd.
23-24 Tafarnaubach Industrial Estate
Tredegar, Gwent, South Wales NP22 3AA UK

Product: Ospemifene 60 mg Tablets

Quantity: 1250 blisters/carton, 36 cartons/pallet
Principal Display Panel

NDC 59630-580-30
Rx Only
30 tablets
(Two blister cards of 15 tablets each)
Osphena
(ospemifene) Tablets
60 mg
OSPHENA
ospemifene tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59630-580
Route of Administration ORAL DEA Schedule  
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OSPEMIFENE (OSPEMIFENE) OSPEMIFENE 60 mg
 
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE  
HYPROMELLOSES  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
MANNITOL  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOLS  
POVIDONES  
TITANIUM DIOXIDE  
TRIACETIN  
STARCH, CORN  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
 
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL (oval biconvex) Size 12mm
Flavor   Imprint Code 60
Contains  
 
Packaging
# Item Code Package Description
1 NDC:59630-580-00 36 in 1 CONTAINER
1   600 in 1 CARTON
1   15 in 1 BLISTER PACK
2 NDC:59630-580-30 2 in 1 PACKAGE
2   15 in 1 BLISTER PACK
3 NDC:59630-580-50 36 in 1 CONTAINER
3   1250 in 1 CARTON
3   5 in 1 BLISTER PACK
4 NDC:59630-580-10 100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203505 02/26/2013  
 
Labeler - Shionogi Inc. (949127786)

Revised: 02/2013
Document Id: 3e160539-49cf-4291-9c7f-cec2674e5aac
Set id: 8462d6ab-e3cd-4efa-a360-75bf8f917287
Version: 11
Effective Time: 20130227