capecitabine

Generic: capecitabine

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

capecitabine 500 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-775
Product ID 31722-775_16a9493c-09be-f35b-e063-6394a90a687e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210203
Listing Expiration 2026-12-31
Marketing Start 2024-03-05

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 31722775
Hyphenated Format 31722-775

Supplemental Identifiers

RxCUI
200327 200328
UPC
0331722774604 0331722775120
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
  • 500 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (31722-775-12)
  • 60 TABLET, FILM COATED in 1 BOTTLE (31722-775-60)
source: ndc

Packages (2)

31722-775-12 120 TABLET, FILM COATED in 1 BOTTLE (31722-775-12) 31722-775-60 60 TABLET, FILM COATED in 1 BOTTLE (31722-775-60)

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": "16a9493c-09be-f35b-e063-6394a90a687e", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0331722774604", "0331722775120"], "unii": ["6804DJ8Z9U"], "rxcui": ["200327", "200328"], "spl_set_id": ["3e7d6317-1439-4976-ae00-6f62619ec3dd"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (31722-775-12)", "package_ndc": "31722-775-12", "marketing_start_date": "20240305"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (31722-775-60)", "package_ndc": "31722-775-60", "marketing_start_date": "20240419"}], "brand_name": "capecitabine", "product_id": "31722-775_16a9493c-09be-f35b-e063-6394a90a687e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "31722-775", "generic_name": "capecitabine", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "capecitabine", "active_ingredients": [{"name": "CAPECITABINE", "strength": "500 mg/1"}], "application_number": "ANDA210203", "marketing_category": "ANDA", "marketing_start_date": "20240305", "listing_expiration_date": "20261231"}