hydroxyurea

Generic: hydroxyurea

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyurea
Generic Name hydroxyurea
Labeler teva pharmaceuticals usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

hydroxyurea 500 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0555-0882
Product ID 0555-0882_9d7feae3-66af-434e-b5dc-569e8ce56b80
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075143
Listing Expiration 2026-12-31
Marketing Start 1998-10-19

Pharmacologic Class

Established (EPC)
antimetabolite [epc]
Chemical Structure
urea [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05550882
Hyphenated Format 0555-0882

Supplemental Identifiers

RxCUI
197797
UPC
0305550882022
UNII
X6Q56QN5QC
NUI
N0000180853 M0022315

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name hydroxyurea (source: ndc)
Generic Name hydroxyurea (source: ndc)
Application Number ANDA075143 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0555-0882-02)
source: ndc

Packages (1)

0555-0882-02 100 CAPSULE in 1 BOTTLE (0555-0882-02)

Ingredients (1)

hydroxyurea (500 mg/1)

Linked Drug Pages (1)

HYDROXYUREA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9d7feae3-66af-434e-b5dc-569e8ce56b80", "openfda": {"nui": ["N0000180853", "M0022315"], "upc": ["0305550882022"], "unii": ["X6Q56QN5QC"], "rxcui": ["197797"], "spl_set_id": ["b9514ae5-79ae-4cc2-9d7f-c8f7806d1694"], "pharm_class_cs": ["Urea [CS]"], "pharm_class_epc": ["Antimetabolite [EPC]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0555-0882-02)", "package_ndc": "0555-0882-02", "marketing_start_date": "19981019"}], "brand_name": "HYDROXYUREA", "product_id": "0555-0882_9d7feae3-66af-434e-b5dc-569e8ce56b80", "dosage_form": "CAPSULE", "pharm_class": ["Antimetabolite [EPC]", "Urea [CS]"], "product_ndc": "0555-0882", "generic_name": "Hydroxyurea", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROXYUREA", "active_ingredients": [{"name": "HYDROXYUREA", "strength": "500 mg/1"}], "application_number": "ANDA075143", "marketing_category": "ANDA", "marketing_start_date": "19981019", "listing_expiration_date": "20261231"}