CAPECITABINE

Product NDC
68001-487
11-digit product format
680010487
Labeler code
68001
Product ID
68001-487_fcfd1ff2-e3d6-dfff-e053-6394a90ababe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CAPECITABINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA202593
Marketing category
ANDA
Marketing start
2021-02-22
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
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
CAPECITABINE150 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
68001-487-06CAPECITABINE60 in 1 BOTTLE, PLASTICTABLET, FILM COATED603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-487-06EA - Each68001-487df409126-d132-44ba-8d8a-76375d02297212021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-487CAPECITABINE TABLET, FILM COATED [BLUEPOINT LABORATORIES]3Current NDC, Legacy NDC, 1 package rows20230601_bbb12406-ce02-3f31-e053-2995a90a0b16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200327capecitabine 150 MG Oral TabletPSNbbb12406-ce02-3f31-e053-2995a90a0b163
200328capecitabine 500 MG Oral TabletPSNbbb12406-ce02-3f31-e053-2995a90a0b163
200327capecitabine 150 MG Oral TabletSCDbbb12406-ce02-3f31-e053-2995a90a0b163
200328capecitabine 500 MG Oral TabletSCDbbb12406-ce02-3f31-e053-2995a90a0b163

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-487-066800104870660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68001-487-06) 2021-02-220000-00-00NoNoCurrent