FDA.reportPublic FDA data

Capecitabine Tablets, 500 mg

Manufacturer
Prodigy Innovation, LLC.
Effective date
2019-04-21
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:24

Label at a glance#

ProductCapecitabine Tablets, 150 mg
Active ingredientCAPECITABINE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Capecitabine TabletsCapecitabine TabletsCapecitabine TabletsCapecitabine Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
200327capecitabine 150 MG Oral TabletPSN1
200328capecitabine 500 MG Oral TabletPSN1
200327capecitabine 150 MG Oral TabletSCD1
200328capecitabine 500 MG Oral TabletSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CAPECITABINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
70297-003-022021-01-29C16284748780-1ba0f9c33-58e3-a910-e053-dadaa90a0b85Capecitabine Tablets, USP 150 mg and 500 mg
70297-004-022021-01-29C16284748780-1ba0f9c33-58e3-a910-e053-dadaa90a0b85Capecitabine Tablets, USP 150 mg and 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70297-003-02Capecitabine Tablets, 150 mg25000 in 1 BAGTABLET250001
70297-004-02Capecitabine Tablets, 500 mg25000 in 1 BAGTABLET250001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70297-003CAPECITABINE TABLETS, 150 MG TABLET CAPECITABINE TABLETS, 500 MG TABLET [PRODIGY INNOVATION, LLC.]11 package rows20190501_87173e7c-6e29-2e85-e053-2a91aa0ae4ae.zip
70297-004CAPECITABINE TABLETS, 150 MG TABLET CAPECITABINE TABLETS, 500 MG TABLET [PRODIGY INNOVATION, LLC.]11 package rows20190501_87173e7c-6e29-2e85-e053-2a91aa0ae4ae.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70297-00370297-003-02
70297-00470297-004-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPECITABINE6804DJ8Z9UACTIB
MICROCRYSTALLINE CELLULOSE 102PNR0YF693YIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MICROCRYSTALLINE CELLULOSE 102PNR0YF693YIACT
CAPECITABINE6804DJ8Z9UACTIB
MAGNESIUM STEARATE70097M6I30IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
87173e7c-6e2a-2e85-e053-2a91aa0ae4ae87173e7c-6e29-2e85-e053-2a91aa0ae4ae2019-04-21Exact identifier
spl id: 87173e7c-6e2a-2e85-e053-2a91aa0ae4ae
spl set id: 87173e7c-6e29-2e85-e053-2a91aa0ae4ae

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.