hydroxyurea

Generic: hydroxyurea

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

hydroxyurea 500 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6939
Product ID 0904-6939_554e6427-7d26-4f99-b69b-10468b9bb014
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075340
Listing Expiration 2026-12-31
Marketing Start 1999-02-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046939
Hyphenated Format 0904-6939

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 ANDA075340 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-6939-61) / 1 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6939-61 100 BLISTER PACK in 1 CARTON (0904-6939-61) / 1 CAPSULE in 1 BLISTER PACK

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": "554e6427-7d26-4f99-b69b-10468b9bb014", "openfda": {"nui": ["N0000180853", "M0022315"], "unii": ["X6Q56QN5QC"], "rxcui": ["197797"], "spl_set_id": ["e76fd60e-7644-48c5-9857-3608a045000b"], "pharm_class_cs": ["Urea [CS]"], "pharm_class_epc": ["Antimetabolite [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6939-61)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "0904-6939-61", "marketing_start_date": "19990224"}], "brand_name": "Hydroxyurea", "product_id": "0904-6939_554e6427-7d26-4f99-b69b-10468b9bb014", "dosage_form": "CAPSULE", "pharm_class": ["Antimetabolite [EPC]", "Urea [CS]"], "product_ndc": "0904-6939", "generic_name": "Hydroxyurea", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyurea", "active_ingredients": [{"name": "HYDROXYUREA", "strength": "500 mg/1"}], "application_number": "ANDA075340", "marketing_category": "ANDA", "marketing_start_date": "19990224", "listing_expiration_date": "20261231"}