Capecitabine

Product NDC
62756-239
11-digit product format
627560239
Labeler code
62756
Product ID
62756-239_8a24ef3b-b59a-4051-bf0d-a98eb6187ef2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Capecitabine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA204668
Marketing category
ANDA
Marketing start
2019-09-01
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
62756-239-18Capecitabine1000 in 1 BOTTLETABLET, FILM COATED10005
62756-239-20Capecitabine120 in 1 BOTTLETABLET, FILM COATED1205
62756-239-83Capecitabine30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-239CAPECITABINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]5Current NDC, Legacy NDC, 3 package rows20230613_e3b1a2b5-f1ce-45ea-afd8-68aac53665fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200327capecitabine 150 MG Oral TabletPSNe3b1a2b5-f1ce-45ea-afd8-68aac53665fa5
200328capecitabine 500 MG Oral TabletPSNe3b1a2b5-f1ce-45ea-afd8-68aac53665fa5
200327capecitabine 150 MG Oral TabletSCDe3b1a2b5-f1ce-45ea-afd8-68aac53665fa5
200328capecitabine 500 MG Oral TabletSCDe3b1a2b5-f1ce-45ea-afd8-68aac53665fa5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62756-239-18627560239181000 TABLET, FILM COATED in 1 BOTTLE (62756-239-18) 2019-09-010000-00-00NoNoCurrent
62756-239-2062756023920120 TABLET, FILM COATED in 1 BOTTLE (62756-239-20) 2019-09-010000-00-00NoNoCurrent
62756-239-836275602398330 TABLET, FILM COATED in 1 BOTTLE (62756-239-83) 2019-09-010000-00-00NoNoCurrent