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, USP, for oral useInitial U.S. Approval: 1967 Warnings and Precautions, Pulmonary Toxicity (5.9) 7/2019
Approved
Approval ID
9e1bdd4b-043a-4cf6-b1ff-8de49e02b7a6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 22, 2021
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
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 Code49884-724
Application NumberANDA075340
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydroxyurea
Product Specifications
Route of AdministrationORAL
Effective DateNovember 22, 2021
FDA Product Classification
INGREDIENTS (8)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYUREAActive
Quantity: 500 mg in 1 1
Code: X6Q56QN5QC
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT