capecitabine

Generic: capecitabine

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

capecitabine 500 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-459
Product ID 67877-459_1979fce8-8d4b-416c-b437-bcd4fc1232ec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207652
Listing Expiration 2027-12-31
Marketing Start 2017-11-25

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 67877459
Hyphenated Format 67877-459

Supplemental Identifiers

RxCUI
200327 200328
UPC
0367877458601 0367877459127
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 ANDA207652 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (67877-459-12)
  • 30 TABLET, FILM COATED in 1 BOTTLE (67877-459-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (67877-459-60)
source: ndc

Packages (3)

67877-459-12 120 TABLET, FILM COATED in 1 BOTTLE (67877-459-12) 67877-459-30 30 TABLET, FILM COATED in 1 BOTTLE (67877-459-30) 67877-459-60 60 TABLET, FILM COATED in 1 BOTTLE (67877-459-60)

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": "1979fce8-8d4b-416c-b437-bcd4fc1232ec", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0367877458601", "0367877459127"], "unii": ["6804DJ8Z9U"], "rxcui": ["200327", "200328"], "spl_set_id": ["06a88b03-6c06-4dae-b3bc-1e8dd81c9067"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (67877-459-12)", "package_ndc": "67877-459-12", "marketing_start_date": "20190501"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (67877-459-30)", "package_ndc": "67877-459-30", "marketing_start_date": "20171125"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (67877-459-60)", "package_ndc": "67877-459-60", "marketing_start_date": "20171125"}], "brand_name": "Capecitabine", "product_id": "67877-459_1979fce8-8d4b-416c-b437-bcd4fc1232ec", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "67877-459", "generic_name": "Capecitabine", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Capecitabine", "active_ingredients": [{"name": "CAPECITABINE", "strength": "500 mg/1"}], "application_number": "ANDA207652", "marketing_category": "ANDA", "marketing_start_date": "20171125", "listing_expiration_date": "20271231"}