MedPath

DROXIA

These highlights do not include all the information needed to use DROXIA safely and effectively. See full prescribing information for DROXIA.DROXIA (hydroxyurea) capsules, for oral useInitial U.S. Approval: 1967

Approved
Approval ID

740e054b-faac-7c27-f06d-a56efb699355

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 15, 2022

Manufacturers
FDA

E.R. Squibb & Sons, L.L.C.

DUNS: 011550092

Products 3

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 Code0003-6337
Application NumberNDA016295
Product Classification
M
Marketing Category
C73594
G
Generic Name
HYDROXYUREA
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2022
FDA Product Classification

INGREDIENTS (10)

hydroxyureaActive
Quantity: 400 mg in 1 1
Code: X6Q56QN5QC
Classification: ACTIB
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
sodium phosphateInactive
Code: SE337SVY37
Classification: IACT
D&C Red No. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
D&C Red No. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT

HYDROXYUREA

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0003-6335
Application NumberNDA016295
Product Classification
M
Marketing Category
C73594
G
Generic Name
HYDROXYUREA
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2022
FDA Product Classification

INGREDIENTS (9)

hydroxyureaActive
Quantity: 200 mg in 1 1
Code: X6Q56QN5QC
Classification: ACTIB
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
sodium phosphateInactive
Code: SE337SVY37
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C Green No. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT

HYDROXYUREA

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0003-6336
Application NumberNDA016295
Product Classification
M
Marketing Category
C73594
G
Generic Name
HYDROXYUREA
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2022
FDA Product Classification

INGREDIENTS (10)

FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
hydroxyureaActive
Quantity: 300 mg in 1 1
Code: X6Q56QN5QC
Classification: ACTIB
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
D&C Red No. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
sodium phosphateInactive
Code: SE337SVY37
Classification: IACT
D&C Red No. 28Inactive
Code: 767IP0Y5NH
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.