droxia

Generic: hydroxyurea

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

Drug Facts

Product Profile

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

hydroxyurea 200 mg/1

Manufacturer
Waylis Therapeutics LLC

Identifiers & Regulatory

Product NDC 80725-820
Product ID 80725-820_3feae4e9-790a-41c7-94df-6baf3ec503ff
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 80725820
Hyphenated Format 80725-820

Supplemental Identifiers

RxCUI
200342 200343 200344 213282 213283 213284
UPC
0380725820603 0380725830602
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 droxia (source: ndc)
Generic Name hydroxyurea (source: ndc)
Application Number NDA016295 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (80725-820-60)
source: ndc

Packages (1)

80725-820-60 60 CAPSULE in 1 BOTTLE (80725-820-60)

Ingredients (1)

hydroxyurea (200 mg/1)

Linked Drug Pages (1)

DROXIA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3feae4e9-790a-41c7-94df-6baf3ec503ff", "openfda": {"nui": ["N0000180853", "M0022315"], "upc": ["0380725820603", "0380725830602"], "unii": ["X6Q56QN5QC"], "rxcui": ["200342", "200343", "200344", "213282", "213283", "213284"], "spl_set_id": ["4ad13dc6-a2ab-4308-96b3-7c642c92cc23"], "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": "60 CAPSULE in 1 BOTTLE (80725-820-60)", "package_ndc": "80725-820-60", "marketing_start_date": "20250911"}], "brand_name": "DROXIA", "product_id": "80725-820_3feae4e9-790a-41c7-94df-6baf3ec503ff", "dosage_form": "CAPSULE", "pharm_class": ["Antimetabolite [EPC]", "Urea [CS]"], "product_ndc": "80725-820", "generic_name": "Hydroxyurea", "labeler_name": "Waylis Therapeutics LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DROXIA", "active_ingredients": [{"name": "HYDROXYUREA", "strength": "200 mg/1"}], "application_number": "NDA016295", "marketing_category": "NDA", "marketing_start_date": "20250911", "listing_expiration_date": "20261231"}