Capecitabine 500mg

Product NDC
72485-205
11-digit product format
724850205
Labeler code
72485
Product ID
72485-205_dad6f70f-70c9-4152-bd36-9cb3537239da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Capecitabine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Armas Pharmaceuticals Inc.
Application
ANDA207456
Marketing category
ANDA
Marketing start
2019-03-01
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 500mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPECITABINE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6804DJ8Z9U
Rxcui200328

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
72485-205-12Capecitabine 500mg120 in 1 BOTTLETABLET, FILM COATED1203
72485-205-12Capecitabine 500mg1 in 1 CARTONTABLET, FILM COATED13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-205-12EA - Each72485-2059f9ad30b-d3d4-493b-a66f-0e35c879417312019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-205CAPECITABINE 500MG (CAPECITABINE) TABLET, FILM COATED [ARMAS PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20201227_f050d16c-ab76-489d-b92c-8c155b4e3f7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200328capecitabine 500 MG Oral TabletPSNf050d16c-ab76-489d-b92c-8c155b4e3f7c3
200328capecitabine 500 MG Oral TabletSCDf050d16c-ab76-489d-b92c-8c155b4e3f7c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72485-205-12724850205121 BOTTLE in 1 CARTON (72485-205-12) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-03-010000-00-00NoNoCurrent