xeloda

Generic: capecitabine

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

Drug Facts

Product Profile

Brand Name xeloda
Generic Name capecitabine
Labeler h2-pharma, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

capecitabine 500 mg/1

Manufacturer
H2-Pharma, LLC

Identifiers & Regulatory

Product NDC 61269-475
Product ID 61269-475_32dd0155-c5cb-49c2-9b74-74f40df22df7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020896
Listing Expiration 2027-12-31
Marketing Start 1998-04-30

Pharmacologic Class

Established (EPC)
nucleoside metabolic inhibitor [epc]
Mechanism of Action
nucleic acid synthesis inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61269475
Hyphenated Format 61269-475

Supplemental Identifiers

RxCUI
200327 200328 213292 213293
UNII
6804DJ8Z9U
NUI
N0000000233 N0000175595

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 xeloda (source: ndc)
Generic Name capecitabine (source: ndc)
Application Number NDA020896 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61269-475-12)
source: ndc

Packages (1)

61269-475-12 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61269-475-12)

Ingredients (1)

capecitabine (500 mg/1)

Linked Drug Pages (1)

XELODA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "32dd0155-c5cb-49c2-9b74-74f40df22df7", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["6804DJ8Z9U"], "rxcui": ["200327", "200328", "213292", "213293"], "spl_set_id": ["e702d84d-7162-4751-bf37-d724cc7e45a5"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["H2-Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61269-475-12)", "package_ndc": "61269-475-12", "marketing_start_date": "19980430"}], "brand_name": "XELODA", "product_id": "61269-475_32dd0155-c5cb-49c2-9b74-74f40df22df7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "61269-475", "generic_name": "capecitabine", "labeler_name": "H2-Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XELODA", "active_ingredients": [{"name": "CAPECITABINE", "strength": "500 mg/1"}], "application_number": "NDA020896", "marketing_category": "NDA", "marketing_start_date": "19980430", "listing_expiration_date": "20271231"}