hydroxyurea

Generic: hydroxyurea

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyurea
Generic Name hydroxyurea
Labeler leading pharma, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

hydroxyurea 500 mg/1

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-164
Product ID 69315-164_3706a800-8ea5-4593-9c7b-5083978b559b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213438
Listing Expiration 2026-12-31
Marketing Start 2020-07-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69315164
Hyphenated Format 69315-164

Supplemental Identifiers

RxCUI
197797
UPC
0369315164013
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 ANDA213438 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (69315-164-01)
source: ndc

Packages (1)

69315-164-01 100 CAPSULE in 1 BOTTLE, PLASTIC (69315-164-01)

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": "3706a800-8ea5-4593-9c7b-5083978b559b", "openfda": {"nui": ["N0000180853", "M0022315"], "upc": ["0369315164013"], "unii": ["X6Q56QN5QC"], "rxcui": ["197797"], "spl_set_id": ["4c4e1c2f-2143-44f3-8825-aeba42e755e4"], "pharm_class_cs": ["Urea [CS]"], "pharm_class_epc": ["Antimetabolite [EPC]"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (69315-164-01)", "package_ndc": "69315-164-01", "marketing_start_date": "20200709"}], "brand_name": "HYDROXYUREA", "product_id": "69315-164_3706a800-8ea5-4593-9c7b-5083978b559b", "dosage_form": "CAPSULE", "pharm_class": ["Antimetabolite [EPC]", "Urea [CS]"], "product_ndc": "69315-164", "generic_name": "HYDROXYUREA", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDROXYUREA", "active_ingredients": [{"name": "HYDROXYUREA", "strength": "500 mg/1"}], "application_number": "ANDA213438", "marketing_category": "ANDA", "marketing_start_date": "20200709", "listing_expiration_date": "20261231"}