Nitisinone
These highlights do not include all the information needed to use NITISINONE CAPSULES safely and effectively. See full prescribing information for NITISINONE CAPSULES. NITISINONE capsules, for oral use.Initial U.S. Approval: 2002
Approved
Approval ID
437868f5-1c9e-4b0f-8a03-77df8ac0900d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 23, 2019
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nitisinone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0254-3022
Application NumberANDA211041
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nitisinone
Product Specifications
Route of AdministrationORAL
Effective DateNovember 12, 2019
FDA Product Classification
INGREDIENTS (12)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
NITISINONEActive
Quantity: 10 mg in 1 1
Code: K5BN214699
Classification: ACTIB
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
Nitisinone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0254-3020
Application NumberANDA211041
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nitisinone
Product Specifications
Route of AdministrationORAL
Effective DateNovember 12, 2019
FDA Product Classification
INGREDIENTS (12)
NITISINONEActive
Quantity: 2 mg in 1 1
Code: K5BN214699
Classification: ACTIB
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
Nitisinone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0254-3021
Application NumberANDA211041
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nitisinone
Product Specifications
Route of AdministrationORAL
Effective DateNovember 12, 2019
FDA Product Classification
INGREDIENTS (12)
NITISINONEActive
Quantity: 5 mg in 1 1
Code: K5BN214699
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT