Capecitabine

Product NDC
59651-205
11-digit product format
596510205
Labeler code
59651
Product ID
59651-205_aabd86be-2d1e-46dc-a31f-9a3cb28e94f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Capecitabine
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA210604
Marketing category
ANDA
Marketing start
2018-04-17
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
59651-205-08Capecitabine120 in 1 BOTTLETABLET1206
59651-205-10Capecitabine1 in 1 CARTONTABLET16
59651-205-10Capecitabine10 in 1 BLISTER PACKTABLET106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-205-08EA - Each59651-205ba823454-c18b-4f00-89c3-c91252d99e8112019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-205CAPECITABINE TABLET [AUROBINDO PHARMA LIMITED]6Current NDC, Legacy NDC, 3 package rows20230513_56441153-a1e5-4fdc-96d6-f21baa6b5fbe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200327capecitabine 150 MG Oral TabletPSN56441153-a1e5-4fdc-96d6-f21baa6b5fbe6
200328capecitabine 500 MG Oral TabletPSN56441153-a1e5-4fdc-96d6-f21baa6b5fbe6
200327capecitabine 150 MG Oral TabletSCD56441153-a1e5-4fdc-96d6-f21baa6b5fbe6
200328capecitabine 500 MG Oral TabletSCD56441153-a1e5-4fdc-96d6-f21baa6b5fbe6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-205-0859651020508120 TABLET in 1 BOTTLE (59651-205-08) 120 tablet2018-04-170000-00-00NoNoCurrent
59651-205-10596510205101 BLISTER PACK in 1 CARTON (59651-205-10) / 10 TABLET in 1 BLISTER PACK1 blister pack2018-04-170000-00-00NoNoCurrent