Capecitabine

Product NDC
72205-007
11-digit product format
722050007
Labeler code
72205
Product ID
72205-007_136d5048-1342-4a83-b6ce-db9f8933741c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Capecitabine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA209365
Marketing category
ANDA
Marketing start
2018-07-21
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
72205-007-92Capecitabine120 in 1 BOTTLETABLET, FILM COATED1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-007-92EA - Each72205-00713f4e96b-b2db-49ee-b606-087b474e0aa012018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-007CAPECITABINE TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC]4Current NDC, Legacy NDC, 1 package rows20240820_29885ada-b743-419c-8f15-edd4247c76ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200327capecitabine 150 MG Oral TabletPSN29885ada-b743-419c-8f15-edd4247c76ca4
200328capecitabine 500 MG Oral TabletPSN29885ada-b743-419c-8f15-edd4247c76ca4
200327capecitabine 150 MG Oral TabletSCD29885ada-b743-419c-8f15-edd4247c76ca4
200328capecitabine 500 MG Oral TabletSCD29885ada-b743-419c-8f15-edd4247c76ca4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72205-007-9272205000792120 TABLET, FILM COATED in 1 BOTTLE (72205-007-92) 2018-07-210000-00-00NoNoCurrent