FDA.reportPublic FDA data

Capecitabine

Product NDC
59923-721
11-digit product format
599230721
Labeler code
59923
Product ID
59923-721_b8e44f52-4f4f-e904-e053-2a95a90a1438
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Capecitabine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Areva Pharmaceuticals
Application
ANDA207456
Marketing category
ANDA
Marketing start
2020-03-01
Marketing end
0000-00-00
Substance
CAPECITABINE
Active strength
150 mg/1
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59923-721-602024-11-04C16284748780-11030e365-08b6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CAPECITABINE TABLETS safely and effectively. See full prescribing information for CAPECITABINE TABLETS. CAPECITABINE tablets, for oral use Initial U.S. Approval: 1998
59923-721-602024-01-30C16284748780-11030e365-08b6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CAPECITABINE TABLETS safely and effectively. See full prescribing information for CAPECITABINE TABLETS. CAPECITABINE tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59923-721-60Capecitabine60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59923-721-60EA - Each59923-7219f19eaa8-be96-4714-8d26-a4cebaed0d1912020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59923-721CAPECITABINE TABLET, FILM COATED [AREVA PHARMACEUTICALS]3Legacy NDC, 1 package rows20241105_9ec7f840-e746-ded8-e053-2995a90ab3a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200327capecitabine 150 MG Oral TabletPSN9ec7f840-e746-ded8-e053-2995a90ab3a23
200328capecitabine 500 MG Oral TabletPSN9ec7f840-e746-ded8-e053-2995a90ab3a23
200327capecitabine 150 MG Oral TabletSCD9ec7f840-e746-ded8-e053-2995a90ab3a23
200328capecitabine 500 MG Oral TabletSCD9ec7f840-e746-ded8-e053-2995a90ab3a23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59923-721-605992307216060 TABLET, FILM COATED in 1 BOTTLE (59923-721-60) 2020-03-010000-00-00NoNoCurrent