hydrea

Generic: hydroxyurea

Labeler: h2-pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrea
Generic Name hydroxyurea
Labeler h2-pharma llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

hydroxyurea 500 mg/1

Manufacturer
H2-Pharma LLC

Identifiers & Regulatory

Product NDC 61269-835
Product ID 61269-835_936d1231-1661-44c9-9eb9-0de1d3bf48cb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA016295
Listing Expiration 2027-12-31
Marketing Start 2009-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61269835
Hyphenated Format 61269-835

Supplemental Identifiers

RxCUI
105602 197797
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 hydrea (source: ndc)
Generic Name hydroxyurea (source: ndc)
Application Number NDA016295 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (61269-835-10)
source: ndc

Packages (1)

61269-835-10 100 CAPSULE in 1 BOTTLE (61269-835-10)

Ingredients (1)

hydroxyurea (500 mg/1)

Linked Drug Pages (1)

HYDREA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "936d1231-1661-44c9-9eb9-0de1d3bf48cb", "openfda": {"nui": ["N0000180853", "M0022315"], "unii": ["X6Q56QN5QC"], "rxcui": ["105602", "197797"], "spl_set_id": ["6053c775-68de-45e4-9af9-33b18fd0e140"], "pharm_class_cs": ["Urea [CS]"], "pharm_class_epc": ["Antimetabolite [EPC]"], "manufacturer_name": ["H2-Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (61269-835-10)", "package_ndc": "61269-835-10", "marketing_start_date": "20090601"}], "brand_name": "HYDREA", "product_id": "61269-835_936d1231-1661-44c9-9eb9-0de1d3bf48cb", "dosage_form": "CAPSULE", "pharm_class": ["Antimetabolite [EPC]", "Urea [CS]"], "product_ndc": "61269-835", "generic_name": "HYDROXYUREA", "labeler_name": "H2-Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDREA", "active_ingredients": [{"name": "HYDROXYUREA", "strength": "500 mg/1"}], "application_number": "NDA016295", "marketing_category": "NDA", "marketing_start_date": "20090601", "listing_expiration_date": "20271231"}