hydroxyurea

Generic: hydroxyurea

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

hydroxyurea 500 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-321
Product ID 42291-321_4133de1c-b333-3b84-e063-6294a90a2432
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075143
Listing Expiration 2026-12-31
Marketing Start 2013-07-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291321
Hyphenated Format 42291-321

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 ANDA075143 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (42291-321-01)
source: ndc

Packages (1)

42291-321-01 100 CAPSULE in 1 BOTTLE (42291-321-01)

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": "4133de1c-b333-3b84-e063-6294a90a2432", "openfda": {"nui": ["N0000180853", "M0022315"], "unii": ["X6Q56QN5QC"], "rxcui": ["197797"], "spl_set_id": ["862583ff-6d5c-3f7d-e3bd-352fb0400928"], "pharm_class_cs": ["Urea [CS]"], "pharm_class_epc": ["Antimetabolite [EPC]"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (42291-321-01)", "package_ndc": "42291-321-01", "marketing_start_date": "20130723"}], "brand_name": "HYDROXYUREA", "product_id": "42291-321_4133de1c-b333-3b84-e063-6294a90a2432", "dosage_form": "CAPSULE", "pharm_class": ["Antimetabolite [EPC]", "Urea [CS]"], "product_ndc": "42291-321", "generic_name": "Hydroxyurea", "labeler_name": "AvKARE", "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": "20130723", "listing_expiration_date": "20261231"}