Capecitabine

Product NDC
0093-7474
11-digit product format
000937474
Labeler code
0093
Product ID
0093-7474_94cd2146-70ff-43e3-a896-b9e55d75540f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Capecitabine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA091649
Marketing category
ANDA
Marketing start
2014-03-07
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Capecitabine
Listing expiration
2027-12-31

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
0093-7474-89Capecitabine120 in 1 BOTTLETABLET, FILM COATED12014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7474CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]13Current NDC, Legacy NDC, 1 package rows20240815_5753679a-506c-4ac4-b8b2-b27c664d1d40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200327capecitabine 150 MG Oral TabletPSN5753679a-506c-4ac4-b8b2-b27c664d1d4014
200328capecitabine 500 MG Oral TabletPSN5753679a-506c-4ac4-b8b2-b27c664d1d4014
200327capecitabine 150 MG Oral TabletSCD5753679a-506c-4ac4-b8b2-b27c664d1d4014
200328capecitabine 500 MG Oral TabletSCD5753679a-506c-4ac4-b8b2-b27c664d1d4014
200328capecitabine 500 MG Oral TabletPSN2777b481-7d7f-461a-b5e0-c09ce2990c349
200328capecitabine 500 MG Oral TabletSCD2777b481-7d7f-461a-b5e0-c09ce2990c349
200327capecitabine 150 MG Oral TabletPSNe28a5ef7-4731-f8ac-e053-2995a90a21bf5
200328capecitabine 500 MG Oral TabletPSNe28a5ef7-4731-f8ac-e053-2995a90a21bf5
200327capecitabine 150 MG Oral TabletSCDe28a5ef7-4731-f8ac-e053-2995a90a21bf5
200328capecitabine 500 MG Oral TabletSCDe28a5ef7-4731-f8ac-e053-2995a90a21bf5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-7474-8900093747489120 TABLET, FILM COATED in 1 BOTTLE (0093-7474-89) 2014-03-070000-00-00NoNoCurrent