Capecitabine

Product NDC
70756-816
11-digit product format
707560816
Labeler code
70756
Product ID
70756-816_42b31bbf-e149-216a-e063-6394a90ae1d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Capecitabine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
ANDA211724
Marketing category
ANDA
Marketing start
2020-09-01
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
70756-816-22Capecitabine120 in 1 BOTTLE, PLASTICTABLET, FILM COATED1208

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-816CAPECITABINE TABLET, FILM COATED [LIFESTAR PHARMA LLC]7Current NDC, Legacy NDC, 1 package rows20230225_643a31d6-0e30-4602-a9b4-355fe944bfea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200327capecitabine 150 MG Oral TabletPSN643a31d6-0e30-4602-a9b4-355fe944bfea8
200328capecitabine 500 MG Oral TabletPSN643a31d6-0e30-4602-a9b4-355fe944bfea8
200327capecitabine 150 MG Oral TabletSCD643a31d6-0e30-4602-a9b4-355fe944bfea8
200328capecitabine 500 MG Oral TabletSCD643a31d6-0e30-4602-a9b4-355fe944bfea8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70756-816-2270756081622120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70756-816-22) 2020-09-010000-00-00NoNoCurrent