hydrea

Generic: hydroxyurea

Labeler: waylis therapeutics llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrea
Generic Name hydroxyurea
Labeler waylis therapeutics llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

hydroxyurea 500 mg/1

Manufacturer
Waylis Therapeutics LLC

Identifiers & Regulatory

Product NDC 80725-810
Product ID 80725-810_d30874b9-8639-44b3-a91b-4fcce90ca484
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA016295
Listing Expiration 2026-12-31
Marketing Start 2025-09-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80725810
Hyphenated Format 80725-810

Supplemental Identifiers

RxCUI
105602 197797
UPC
0380725810109
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 hydrea (source: ndc)
Generic Name hydroxyurea (source: ndc)
Application Number NDA016295 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (80725-810-10)
source: ndc

Packages (1)

80725-810-10 100 CAPSULE in 1 BOTTLE, PLASTIC (80725-810-10)

Ingredients (1)

hydroxyurea (500 mg/1)

Linked Drug Pages (1)

HYDREA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d30874b9-8639-44b3-a91b-4fcce90ca484", "openfda": {"nui": ["N0000180853", "M0022315"], "upc": ["0380725810109"], "unii": ["X6Q56QN5QC"], "rxcui": ["105602", "197797"], "spl_set_id": ["8d41152f-a98a-4abc-afdf-a909012434a0"], "pharm_class_cs": ["Urea [CS]"], "pharm_class_epc": ["Antimetabolite [EPC]"], "manufacturer_name": ["Waylis Therapeutics LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (80725-810-10)", "package_ndc": "80725-810-10", "marketing_start_date": "20250911"}], "brand_name": "HYDREA", "product_id": "80725-810_d30874b9-8639-44b3-a91b-4fcce90ca484", "dosage_form": "CAPSULE", "pharm_class": ["Antimetabolite [EPC]", "Urea [CS]"], "product_ndc": "80725-810", "generic_name": "Hydroxyurea", "labeler_name": "Waylis Therapeutics LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDREA", "active_ingredients": [{"name": "HYDROXYUREA", "strength": "500 mg/1"}], "application_number": "NDA016295", "marketing_category": "NDA", "marketing_start_date": "20250911", "listing_expiration_date": "20261231"}