droxia

Generic: hydroxyurea

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

Drug Facts

Product Profile

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

hydroxyurea 300 mg/1

Manufacturer
H2-Pharma LLC

Identifiers & Regulatory

Product NDC 61269-403
Product ID 61269-403_f57fbea0-8124-4877-b7c6-f1b154d8c659
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 61269403
Hyphenated Format 61269-403

Supplemental Identifiers

RxCUI
200342 200343 200344 213282 213283 213284
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 droxia (source: ndc)
Generic Name hydroxyurea (source: ndc)
Application Number NDA016295 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (61269-403-60)
source: ndc

Packages (1)

61269-403-60 60 CAPSULE in 1 BOTTLE (61269-403-60)

Ingredients (1)

hydroxyurea (300 mg/1)

Linked Drug Pages (1)

DROXIA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f57fbea0-8124-4877-b7c6-f1b154d8c659", "openfda": {"nui": ["N0000180853", "M0022315"], "unii": ["X6Q56QN5QC"], "rxcui": ["200342", "200343", "200344", "213282", "213283", "213284"], "spl_set_id": ["a9494409-3571-4a81-9ad3-15ef7cb636a2"], "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": "60 CAPSULE in 1 BOTTLE (61269-403-60)", "package_ndc": "61269-403-60", "marketing_start_date": "20150716"}], "brand_name": "DROXIA", "product_id": "61269-403_f57fbea0-8124-4877-b7c6-f1b154d8c659", "dosage_form": "CAPSULE", "pharm_class": ["Antimetabolite [EPC]", "Urea [CS]"], "product_ndc": "61269-403", "generic_name": "HYDROXYUREA", "labeler_name": "H2-Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DROXIA", "active_ingredients": [{"name": "HYDROXYUREA", "strength": "300 mg/1"}], "application_number": "NDA016295", "marketing_category": "NDA", "marketing_start_date": "20090601", "listing_expiration_date": "20271231"}