Viewing data from:

HYDROXYUREA

ANDA

HYDROXYUREA | A075340 | PH HEALTH LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: HYDREA(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$0.1910

per ea

Lowest NADAC/Unit

$0.1910

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00904693961HYDROXYUREA 500 MG CAPSULE	$0.1910	EA	Generic	—	2026-06-17
49884072401HYDROXYUREA 500 MG CAPSULE	$0.1910	EA	Generic	—	2026-06-17
68084028401HYDROXYUREA 500 MG CAPSULE	$0.1910	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain4 active DMFs6 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

OLON SPAHYDROXYUREA

DMF 118991996

ARCHIMICA SPAHYDROXYUREA

DMF 127541997

SHANDONG ANXIN PHARMACEUTICAL CO LTDHYDROXYUREA USP (NON-STERILE BULK)

DMF 206152007

OLON SPAHYDROXYUREA

DMF 371462022

FERMENTA FRANCE SAInactiveHYDROXYUREA BY OLMACO OF EMPERNON,FRANCE (FORMERLY HELD BY OLMACO)

DMF 22581974

SQUIBBInactiveHYDROXYUREA

DMF 22591974

SQUIBB MARK DIV ER SQUIBB AND SONS INCInactiveHYDROXYUREA LYOPHILIZED POWDER

DMF 83611989

MEDEA RESEARCH LABORATORIES INCInactiveHYDROXYUREA

DMF 92411991

DSM PHARMA CHEMICALS SOUTH HAVEN INCInactiveHYDROXYUREA

DMF 98501992

CHEMSPECInactiveHYDROXYUREA

DMF 164582003

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 24, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 500MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Feb 24, 1999

No patent or exclusivity listings for this strength.