hydroxyurea

Generic: hydroxyurea

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyurea
Generic Name hydroxyurea
Labeler american health packaging
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

hydroxyurea 500 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-284
Product ID 68084-284_4c118bb8-d003-3029-e063-6394a90a7d36
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075340
Listing Expiration 2027-12-31
Marketing Start 2008-09-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68084284
Hyphenated Format 68084-284

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 BOX, UNIT-DOSE (68084-284-01) / 1 CAPSULE in 1 BLISTER PACK (68084-284-11)
source: ndc

Packages (1)

68084-284-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-284-01) / 1 CAPSULE in 1 BLISTER PACK (68084-284-11)

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": "4c118bb8-d003-3029-e063-6394a90a7d36", "openfda": {"nui": ["N0000180853", "M0022315"], "unii": ["X6Q56QN5QC"], "rxcui": ["197797"], "spl_set_id": ["c84a2241-6c05-480f-8a5b-049e08c27d73"], "pharm_class_cs": ["Urea [CS]"], "pharm_class_epc": ["Antimetabolite [EPC]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-284-01)  / 1 CAPSULE in 1 BLISTER PACK (68084-284-11)", "package_ndc": "68084-284-01", "marketing_start_date": "20080917"}], "brand_name": "Hydroxyurea", "product_id": "68084-284_4c118bb8-d003-3029-e063-6394a90a7d36", "dosage_form": "CAPSULE", "pharm_class": ["Antimetabolite [EPC]", "Urea [CS]"], "product_ndc": "68084-284", "generic_name": "Hydroxyurea", "labeler_name": "American Health Packaging", "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": "20080917", "listing_expiration_date": "20271231"}