hydroxyurea

Generic: hydroxyurea

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyurea
Generic Name hydroxyurea
Labeler coupler llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

hydroxyurea 500 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1619
Product ID 67046-1619_44fd4944-cb39-8ec8-e063-6394a90a8588
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218021
Listing Expiration 2026-12-31
Marketing Start 2025-12-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461619
Hyphenated Format 67046-1619

Supplemental Identifiers

RxCUI
197797
UNII
X6Q56QN5QC
NUI
N0000180853 M0022315

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
  • 30 CAPSULE in 1 BLISTER PACK (67046-1619-3)
source: ndc

Packages (1)

67046-1619-3 30 CAPSULE in 1 BLISTER PACK (67046-1619-3)

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": "44fd4944-cb39-8ec8-e063-6394a90a8588", "openfda": {"nui": ["N0000180853", "M0022315"], "unii": ["X6Q56QN5QC"], "rxcui": ["197797"], "spl_set_id": ["44fd5379-5fb0-ff62-e063-6294a90ac792"], "pharm_class_cs": ["Urea [CS]"], "pharm_class_epc": ["Antimetabolite [EPC]"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (67046-1619-3)", "package_ndc": "67046-1619-3", "marketing_start_date": "20251202"}], "brand_name": "HYDROXYUREA", "product_id": "67046-1619_44fd4944-cb39-8ec8-e063-6394a90a8588", "dosage_form": "CAPSULE", "pharm_class": ["Antimetabolite [EPC]", "Urea [CS]"], "product_ndc": "67046-1619", "generic_name": "HYDROXYUREA", "labeler_name": "Coupler 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": "20251202", "listing_expiration_date": "20261231"}