capecitabine

Generic: capecitabine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name capecitabine
Generic Name capecitabine
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

capecitabine 500 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-205
Product ID 59651-205_aabd86be-2d1e-46dc-a31f-9a3cb28e94f4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210604
Listing Expiration 2026-12-31
Marketing Start 2018-04-17

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 59651205
Hyphenated Format 59651-205

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 ANDA210604 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 120 TABLET in 1 BOTTLE (59651-205-08)
  • 1 BLISTER PACK in 1 CARTON (59651-205-10) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

59651-205-08 120 TABLET in 1 BOTTLE (59651-205-08) 59651-205-10 1 BLISTER PACK in 1 CARTON (59651-205-10) / 10 TABLET in 1 BLISTER PACK

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": "aabd86be-2d1e-46dc-a31f-9a3cb28e94f4", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["6804DJ8Z9U"], "rxcui": ["200327", "200328"], "spl_set_id": ["56441153-a1e5-4fdc-96d6-f21baa6b5fbe"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE (59651-205-08)", "package_ndc": "59651-205-08", "marketing_start_date": "20180417"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (59651-205-10)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "59651-205-10", "marketing_start_date": "20180417"}], "brand_name": "Capecitabine", "product_id": "59651-205_aabd86be-2d1e-46dc-a31f-9a3cb28e94f4", "dosage_form": "TABLET", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "59651-205", "generic_name": "Capecitabine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Capecitabine", "active_ingredients": [{"name": "CAPECITABINE", "strength": "500 mg/1"}], "application_number": "ANDA210604", "marketing_category": "ANDA", "marketing_start_date": "20180417", "listing_expiration_date": "20261231"}