capecitabine

Generic: capecitabine

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name capecitabine
Generic Name capecitabine
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

capecitabine 500 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 62756-239
Product ID 62756-239_8a24ef3b-b59a-4051-bf0d-a98eb6187ef2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204668
Listing Expiration 2026-12-31
Marketing Start 2019-09-01

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 62756239
Hyphenated Format 62756-239

Supplemental Identifiers

RxCUI
200327 200328
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 capecitabine (source: ndc)
Generic Name capecitabine (source: ndc)
Application Number ANDA204668 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (62756-239-18)
  • 120 TABLET, FILM COATED in 1 BOTTLE (62756-239-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE (62756-239-83)
source: ndc

Packages (3)

62756-239-18 1000 TABLET, FILM COATED in 1 BOTTLE (62756-239-18) 62756-239-20 120 TABLET, FILM COATED in 1 BOTTLE (62756-239-20) 62756-239-83 30 TABLET, FILM COATED in 1 BOTTLE (62756-239-83)

Ingredients (1)

capecitabine (500 mg/1)

Linked Drug Pages (1)

Capecitabine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8a24ef3b-b59a-4051-bf0d-a98eb6187ef2", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["6804DJ8Z9U"], "rxcui": ["200327", "200328"], "spl_set_id": ["e3b1a2b5-f1ce-45ea-afd8-68aac53665fa"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (62756-239-18)", "package_ndc": "62756-239-18", "marketing_start_date": "20190901"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (62756-239-20)", "package_ndc": "62756-239-20", "marketing_start_date": "20190901"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (62756-239-83)", "package_ndc": "62756-239-83", "marketing_start_date": "20190901"}], "brand_name": "Capecitabine", "product_id": "62756-239_8a24ef3b-b59a-4051-bf0d-a98eb6187ef2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "62756-239", "generic_name": "Capecitabine", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Capecitabine", "active_ingredients": [{"name": "CAPECITABINE", "strength": "500 mg/1"}], "application_number": "ANDA204668", "marketing_category": "ANDA", "marketing_start_date": "20190901", "listing_expiration_date": "20261231"}