CAPECITABINE

Product NDC
16729-073
11-digit product format
167290073
Labeler code
16729
Product ID
16729-073_0e1e6b8e-1e8f-3b26-e063-6294a90ad5fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CAPECITABINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA202593
Marketing category
ANDA
Marketing start
2015-05-20
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
16729-073-29CAPECITABINE120 in 1 BOTTLE, PLASTICTABLET, FILM COATED12013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-073CAPECITABINE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]13Current NDC, Legacy NDC, 1 package rows20240105_8345d55e-ad02-4726-a04b-1a46e3337a4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200327capecitabine 150 MG Oral TabletPSN8345d55e-ad02-4726-a04b-1a46e3337a4b13
200328capecitabine 500 MG Oral TabletPSN8345d55e-ad02-4726-a04b-1a46e3337a4b13
200327capecitabine 150 MG Oral TabletSCD8345d55e-ad02-4726-a04b-1a46e3337a4b13
200328capecitabine 500 MG Oral TabletSCD8345d55e-ad02-4726-a04b-1a46e3337a4b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-073-2916729007329120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-073-29) 2015-05-200000-00-00NoNoCurrent