Capecitabine

Product NDC
82249-210
11-digit product format
822490210
Labeler code
82249
Product ID
82249-210_5a175994-25a9-4271-957f-9d8cc02fbfce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Capecitabine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CivicaScript LLC
Application
ANDA207652
Marketing category
ANDA
Marketing start
2025-06-26
Substance
CAPECITABINE
Active strength
500 mg/1
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Capecitabine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPECITABINE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6804DJ8Z9U
Rxcui200327, 200328

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a5eae620-c3a7-41bb-55a8-fce9c3eb9864Product name920180820

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82249-210-12Capecitabine120 in 1 BOTTLETABLET, FILM COATED1203

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200327capecitabine 150 MG Oral TabletPSN4ec2cfc1-e8ca-4109-8b90-1aab07cbab213
200328capecitabine 500 MG Oral TabletPSN4ec2cfc1-e8ca-4109-8b90-1aab07cbab213
200327capecitabine 150 MG Oral TabletSCD4ec2cfc1-e8ca-4109-8b90-1aab07cbab213
200328capecitabine 500 MG Oral TabletSCD4ec2cfc1-e8ca-4109-8b90-1aab07cbab213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82249-210-1282249021012120 TABLET, FILM COATED in 1 BOTTLE (82249-210-12) 2025-06-26NoNoCurrent