siklos

Generic: hydroxyurea

Labeler: medunik
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name siklos
Generic Name hydroxyurea
Labeler medunik
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydroxyurea 100 mg/1

Manufacturer
Medunik

Identifiers & Regulatory

Product NDC 71770-105
Product ID 71770-105_47d0b61d-ad65-d2e0-e063-6294a90afe50
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208843
Listing Expiration 2027-12-31
Marketing Start 2020-10-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71770105
Hyphenated Format 71770-105

Supplemental Identifiers

RxCUI
283475 1999308 1999314 1999316
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 siklos (source: ndc)
Generic Name hydroxyurea (source: ndc)
Application Number NDA208843 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (71770-105-60) / 60 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

71770-105-60 1 BOTTLE in 1 CARTON (71770-105-60) / 60 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

hydroxyurea (100 mg/1)

Linked Drug Pages (1)

Siklos ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47d0b61d-ad65-d2e0-e063-6294a90afe50", "openfda": {"nui": ["N0000180853", "M0022315"], "unii": ["X6Q56QN5QC"], "rxcui": ["283475", "1999308", "1999314", "1999316"], "spl_set_id": ["76957c0d-0f98-4376-bb06-eee651adc09d"], "pharm_class_cs": ["Urea [CS]"], "pharm_class_epc": ["Antimetabolite [EPC]"], "manufacturer_name": ["Medunik"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (71770-105-60)  / 60 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "71770-105-60", "marketing_start_date": "20201015"}], "brand_name": "Siklos", "product_id": "71770-105_47d0b61d-ad65-d2e0-e063-6294a90afe50", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antimetabolite [EPC]", "Urea [CS]"], "product_ndc": "71770-105", "generic_name": "hydroxyurea", "labeler_name": "Medunik", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Siklos", "active_ingredients": [{"name": "HYDROXYUREA", "strength": "100 mg/1"}], "application_number": "NDA208843", "marketing_category": "NDA", "marketing_start_date": "20201015", "listing_expiration_date": "20271231"}