hydroxyurea

Generic: hydroxyurea

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyurea
Generic Name hydroxyurea
Labeler somerset therapeutics, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

hydroxyurea 500 mg/1

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-820
Product ID 70069-820_1c41acb0-9bab-4c8f-b383-2707e88a120c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218021
Listing Expiration 2026-12-31
Marketing Start 2024-06-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069820
Hyphenated Format 70069-820

Supplemental Identifiers

RxCUI
197797
UPC
0370069820018
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 ANDA218021 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (70069-820-01)
source: ndc

Packages (1)

70069-820-01 100 CAPSULE in 1 BOTTLE (70069-820-01)

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": "1c41acb0-9bab-4c8f-b383-2707e88a120c", "openfda": {"nui": ["N0000180853", "M0022315"], "upc": ["0370069820018"], "unii": ["X6Q56QN5QC"], "rxcui": ["197797"], "spl_set_id": ["9752a347-b42c-44d5-8fd1-c538f7f239dc"], "pharm_class_cs": ["Urea [CS]"], "pharm_class_epc": ["Antimetabolite [EPC]"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (70069-820-01)", "package_ndc": "70069-820-01", "marketing_start_date": "20240618"}], "brand_name": "HYDROXYUREA", "product_id": "70069-820_1c41acb0-9bab-4c8f-b383-2707e88a120c", "dosage_form": "CAPSULE", "pharm_class": ["Antimetabolite [EPC]", "Urea [CS]"], "product_ndc": "70069-820", "generic_name": "HYDROXYUREA", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROXYUREA", "active_ingredients": [{"name": "HYDROXYUREA", "strength": "500 mg/1"}], "application_number": "ANDA218021", "marketing_category": "ANDA", "marketing_start_date": "20240618", "listing_expiration_date": "20261231"}