capecitabine

Generic: capecitabine

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name capecitabine
Generic Name capecitabine
Labeler cipla usa inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

capecitabine 500 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-948
Product ID 69097-948_c1549b67-948e-402d-9ba4-6fc16237df8f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209365
Listing Expiration 2026-12-31
Marketing Start 2023-07-01

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 69097948
Hyphenated Format 69097-948

Supplemental Identifiers

RxCUI
200327 200328
UPC
0369097949037
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 ANDA209365 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (69097-948-08)
source: ndc

Packages (1)

69097-948-08 120 TABLET, FILM COATED in 1 BOTTLE (69097-948-08)

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": "c1549b67-948e-402d-9ba4-6fc16237df8f", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0369097949037"], "unii": ["6804DJ8Z9U"], "rxcui": ["200327", "200328"], "spl_set_id": ["2871c37d-5e55-437b-a434-fc86d845492a"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (69097-948-08)", "package_ndc": "69097-948-08", "marketing_start_date": "20230701"}], "brand_name": "Capecitabine", "product_id": "69097-948_c1549b67-948e-402d-9ba4-6fc16237df8f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "69097-948", "generic_name": "Capecitabine", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Capecitabine", "active_ingredients": [{"name": "CAPECITABINE", "strength": "500 mg/1"}], "application_number": "ANDA209365", "marketing_category": "ANDA", "marketing_start_date": "20230701", "listing_expiration_date": "20261231"}