HYDROXYUREA
These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES.HYDROXYUREA capsules, for oral useInitial U.S. Approval: 1967
Approved
Approval ID
b9514ae5-79ae-4cc2-9d7f-c8f7806d1694
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 7, 2022
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydroxyurea
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0555-0882
Application NumberANDA075143
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydroxyurea
Product Specifications
Route of AdministrationORAL
Effective DateMarch 7, 2022
FDA Product Classification
INGREDIENTS (18)
HYDROXYUREAActive
Quantity: 500 mg in 1 1
Code: X6Q56QN5QC
Classification: ACTIB
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT