Manufactured for
BioMarin Pharmaceutical Inc.,
Novato, CA 94949

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INGREDIENTS AND APPEARANCE
KUVAN 
sapropterin dihydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68135-300
Route of Administration ORAL DEA Schedule     
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SAPROPTERIN DIHYDROCHLORIDE (UNII: RG277LF5B3) (SAPROPTERIN - UNII:EGX657432I) SAPROPTERIN DIHYDROCHLORIDE 100 mg
 
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) 5 mg
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) 13.5 mg
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) 6.54 mg
MANNITOL (UNII: 3OWL53L36A) 171.18 mg
RIBOFLAVIN (UNII: TLM2976OFR) 0.03 mg
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) 3.75 mg
 
Product Characteristics
Color WHITE (off-white to light yellow) Score no score
Shape ROUND Size 10mm
Flavor  Imprint Code 177
Contains     
 
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68135-300-02 120 in 1 BOTTLE; Type 0: Not a Combination Product  
 
 
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022181 12/14/2007 
 
KUVAN 
sapropterin dihydrochloride powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68135-301
Route of Administration ORAL DEA Schedule     
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SAPROPTERIN DIHYDROCHLORIDE (UNII: RG277LF5B3) (SAPROPTERIN - UNII:EGX657432I) SAPROPTERIN DIHYDROCHLORIDE 100 mg
 
Inactive Ingredients
Ingredient Name Strength
MANNITOL (UNII: 3OWL53L36A) 169.1 mg
POTASSIUM CITRATE (UNII: EE90ONI6FF) 32.5 mg
SUCRALOSE (UNII: 96K6UQ3ZD4) 5.9 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) 5 mg
 
Product Characteristics
Color WHITE (off white to yellow) Score     
Shape  Size 
Flavor  Imprint Code 
Contains     
 
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68135-301-22 30 in 1 CARTON  
1 NDC:68135-301-11 1 in 1 PACKET; Type 0: Not a Combination Product  
 
 
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205065 02/21/2014 
 
KUVAN 
sapropterin dihydrochloride powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68135-482
Route of Administration ORAL DEA Schedule     
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SAPROPTERIN DIHYDROCHLORIDE (UNII: RG277LF5B3) (SAPROPTERIN - UNII:EGX657432I) SAPROPTERIN DIHYDROCHLORIDE 500 mg
 
Inactive Ingredients
Ingredient Name Strength
MANNITOL (UNII: 3OWL53L36A) 845.5 mg
ASCORB