capecitabine

Generic: capecitabine

Labeler: teyro labs private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name capecitabine
Generic Name capecitabine
Labeler teyro labs private limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

capecitabine 150 mg/1

Manufacturer
Teyro Labs Private Limited

Identifiers & Regulatory

Product NDC 82511-001
Product ID 82511-001_2b3f98b5-d81c-d87d-e063-6294a90a7e87
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217237
Listing Expiration 2026-12-31
Marketing Start 2022-02-16

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 82511001
Hyphenated Format 82511-001

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 ANDA217237 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82511-001-15)
source: ndc

Packages (1)

82511-001-15 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82511-001-15)

Ingredients (1)

capecitabine (150 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": "2b3f98b5-d81c-d87d-e063-6294a90a7e87", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["6804DJ8Z9U"], "rxcui": ["200327", "200328"], "spl_set_id": ["0c873e5b-51c2-4685-86c5-53f98563b093"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Teyro Labs Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82511-001-15)", "package_ndc": "82511-001-15", "marketing_start_date": "20220901"}], "brand_name": "Capecitabine", "product_id": "82511-001_2b3f98b5-d81c-d87d-e063-6294a90a7e87", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "82511-001", "generic_name": "capecitabine", "labeler_name": "Teyro Labs Private Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Capecitabine", "active_ingredients": [{"name": "CAPECITABINE", "strength": "150 mg/1"}], "application_number": "ANDA217237", "marketing_category": "ANDA", "marketing_start_date": "20220216", "listing_expiration_date": "20261231"}