capecitabine

Generic: capecitabine

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name capecitabine
Generic Name capecitabine
Labeler bluepoint laboratories
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

capecitabine 150 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-643
Product ID 68001-643_498ba415-dab9-ce68-e063-6394a90af1b4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210203
Listing Expiration 2027-12-31
Marketing Start 2025-04-18

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 68001643
Hyphenated Format 68001-643

Supplemental Identifiers

RxCUI
200327 200328
UPC
0368001643061 0368001644075
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 ANDA210203 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (68001-643-06)
source: ndc

Packages (1)

68001-643-06 60 TABLET, FILM COATED in 1 BOTTLE (68001-643-06)

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": "498ba415-dab9-ce68-e063-6394a90af1b4", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0368001643061", "0368001644075"], "unii": ["6804DJ8Z9U"], "rxcui": ["200327", "200328"], "spl_set_id": ["88c5af84-900a-4372-b056-bfea70c129cf"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68001-643-06)", "package_ndc": "68001-643-06", "marketing_start_date": "20250418"}], "brand_name": "Capecitabine", "product_id": "68001-643_498ba415-dab9-ce68-e063-6394a90af1b4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "68001-643", "generic_name": "Capecitabine", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Capecitabine", "active_ingredients": [{"name": "CAPECITABINE", "strength": "150 mg/1"}], "application_number": "ANDA210203", "marketing_category": "ANDA", "marketing_start_date": "20250418", "listing_expiration_date": "20271231"}