capecitabine

Generic: capecitabine

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name capecitabine
Generic Name capecitabine
Labeler quallent pharmaceuticals health llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

capecitabine 500 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-112
Product ID 82009-112_42afca74-0031-860a-7824-317742a8664d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204345
Listing Expiration 2026-12-31
Marketing Start 2023-07-21

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 82009112
Hyphenated Format 82009-112

Supplemental Identifiers

RxCUI
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 ANDA204345 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 120 TABLET in 1 BOTTLE (82009-112-12)
source: ndc

Packages (1)

82009-112-12 120 TABLET in 1 BOTTLE (82009-112-12)

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": "42afca74-0031-860a-7824-317742a8664d", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["6804DJ8Z9U"], "rxcui": ["200328"], "spl_set_id": ["d23f023a-ea62-4ac0-f615-d5d26d59526d"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE (82009-112-12)", "package_ndc": "82009-112-12", "marketing_start_date": "20230721"}], "brand_name": "Capecitabine", "product_id": "82009-112_42afca74-0031-860a-7824-317742a8664d", "dosage_form": "TABLET", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "82009-112", "generic_name": "Capecitabine", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Capecitabine", "active_ingredients": [{"name": "CAPECITABINE", "strength": "500 mg/1"}], "application_number": "ANDA204345", "marketing_category": "ANDA", "marketing_start_date": "20230721", "listing_expiration_date": "20261231"}