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Last Updated: December 12, 2025

List of Excipients in API HYDROXYUREA


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Excipients in NDA-approved (novel) drugs containing HYDROXYUREA

Glossary
Company Tradename Ingredient NDC Excipient Potential Generic Entry
ER Squibb & Sons LLC HYDREA hydroxyurea 0003-0830 CITRIC ACID MONOHYDRATE
ER Squibb & Sons LLC HYDREA hydroxyurea 0003-0830 D&C RED NO. 28
ER Squibb & Sons LLC HYDREA hydroxyurea 0003-0830 D&C YELLOW NO. 10
ER Squibb & Sons LLC HYDREA hydroxyurea 0003-0830 FD&C BLUE NO. 1
ER Squibb & Sons LLC HYDREA hydroxyurea 0003-0830 FD&C RED NO. 40
ER Squibb & Sons LLC HYDREA hydroxyurea 0003-0830 GELATIN
ER Squibb & Sons LLC HYDREA hydroxyurea 0003-0830 LACTOSE
>Company >Tradename >Ingredient >NDC >Excipient >Potential Generic Entry

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Excipients in ANDA-approved (generic) drugs containing HYDROXYUREA

Company Ingredient NDC Excipient
Teva Pharmaceuticals USA Inc hydroxyurea 0555-0882 ANHYDROUS CITRIC ACID
Teva Pharmaceuticals USA Inc hydroxyurea 0555-0882 D&C RED NO. 28
Teva Pharmaceuticals USA Inc hydroxyurea 0555-0882 D&C YELLOW NO. 10 ALUMINUM LAKE
Teva Pharmaceuticals USA Inc hydroxyurea 0555-0882 FD&C BLUE NO. 1
Teva Pharmaceuticals USA Inc hydroxyurea 0555-0882 FD&C BLUE NO. 1 ALUMINUM LAKE
Teva Pharmaceuticals USA Inc hydroxyurea 0555-0882 FD&C BLUE NO. 2--ALUMINUM LAKE
Teva Pharmaceuticals USA Inc hydroxyurea 0555-0882 FD&C RED NO. 40
>Company >Ingredient >NDC >Excipient

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Detailed excipient profiles for HYDROXYUREA

Excipient focus: ALUMINUM OXIDE

Excipient focus: AMMONIA

Excipient focus: ANHYDROUS CITRIC ACID

Excipient focus: ANHYDROUS LACTOSE

Excipient focus: BENZYL ALCOHOL

Excipient focus: BUTYLPARABEN

Excipient focus: CARBOXYMETHYLCELLULOSE SODIUM

Excipient focus: CELLULOSE, MICROCRYSTALLINE

Excipient focus: CITRIC ACID MONOHYDRATE

Excipient focus: D&C RED NO. 28

Excipient focus: D&C RED NO. 33

Excipient focus: D&C YELLOW NO. 10

Excipient focus: D&C YELLOW NO. 10 ALUMINUM LAKE

Excipient focus: DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER

HYDROXYUREA drug variants not containing DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER

Company Ingredient NDC
ER Squibb & Sons LLC hydroxyurea 0003-0830
ER Squibb & Sons LLC hydroxyurea 0003-6336
Teva Pharmaceuticals USA Inc hydroxyurea 0555-0882
Major Pharmaceuticals hydroxyurea 0904-6939
Marlex Pharmaceuticals Inc hydroxyurea 10135-702
AvKARE hydroxyurea 42291-321
Endo USA Inc hydroxyurea 49884-724
>Company >Ingredient >NDC

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Excipient focus: EDETATE CALCIUM DISODIUM

Excipient focus: FD&C BLUE NO. 1

Excipient focus: FD&C BLUE NO. 1 ALUMINUM LAKE

Excipient focus: FD&C BLUE NO. 2

Excipient focus: FD&C BLUE NO. 2 ALUMINUM LAKE

Excipient focus: FD&C BLUE NO. 2--ALUMINUM LAKE

Excipient focus: FD&C GREEN NO. 3

Excipient focus: FD&C RED NO. 3

Excipient focus: FD&C RED NO. 40

Excipient focus: FD&C RED NO. 40 ALUMINUM LAKE

Excipient focus: FERRIC OXIDE RED

Excipient focus: FERROSOFERRIC OXIDE

Excipient focus: GELATIN

Excipient focus: ISOPROPYL ALCOHOL

Excipient focus: LACTOSE

Excipient focus: LACTOSE MONOHYDRATE

Excipient focus: MAGNESIUM STEARATE

Excipient focus: METHYLPARABEN

Excipient focus: POTASSIUM HYDROXIDE

Excipient focus: PROPYLENE GLYCOL

Excipient focus: PROPYLPARABEN SODIUM

Excipient focus: SHELLAC

Excipient focus: SILICON DIOXIDE

Excipient focus: SODIUM LAURYL SULFATE

Excipient focus: SODIUM PHOSPHATE

Excipient focus: SODIUM PHOSPHATE, DIBASIC

Excipient focus: SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

Excipient focus: SODIUM PROPIONATE

Excipient focus: SODIUM STEARYL FUMARATE

Excipient focus: TITANIUM DIOXIDE

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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