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 use Initial U.S. Approval: 1967
Approved
Approval ID
c84a2241-6c05-480f-8a5b-049e08c27d73
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 2, 2023
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydroxyurea
PRODUCT DETAILS
NDC Product Code68084-284
Application NumberANDA075340
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 2, 2023
Generic NameHydroxyurea
INGREDIENTS (13)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYDROXYUREAActive
Quantity: 500 mg in 1 1
Code: X6Q56QN5QC
Classification: ACTIB