capecitabine

Product NDC
55111-496
11-digit product format
551110496
Labeler code
55111
Product ID
55111-496_25eb47d5-42ca-889b-6798-6f91d7795417
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
capecitabine
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA204345
Marketing category
ANDA
Marketing start
2020-12-10
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
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
CAPECITABINE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6804DJ8Z9U
Rxcui200327, 200328

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a5eae620-c3a7-41bb-55a8-fce9c3eb9864Product name920180820

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-496-05capecitabine500 in 1 BOTTLETABLET50015
55111-496-60capecitabine60 in 1 BOTTLETABLET6015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-496-60EA - Each55111-4961a77847f-0e51-4973-9b9b-83378a108ccb12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-496CAPECITABINE TABLET [DR. REDDY'S LABORATORIES LIMITED]13Current NDC, Legacy NDC, 2 package rows20230719_007e3432-c8aa-2a76-52ba-c346924c08a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200327capecitabine 150 MG Oral TabletPSN007e3432-c8aa-2a76-52ba-c346924c08a715
200328capecitabine 500 MG Oral TabletPSN007e3432-c8aa-2a76-52ba-c346924c08a715
200327capecitabine 150 MG Oral TabletSCD007e3432-c8aa-2a76-52ba-c346924c08a715
200328capecitabine 500 MG Oral TabletSCD007e3432-c8aa-2a76-52ba-c346924c08a715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-496-0555111049605500 TABLET in 1 BOTTLE (55111-496-05) 500 tablet2020-12-100000-00-00NoNoCurrent
55111-496-605511104966060 TABLET in 1 BOTTLE (55111-496-60) 60 tablet2020-12-100000-00-00NoNoCurrent