Capecitabine

Product NDC
0054-0272
11-digit product format
000540272
Labeler code
0054
Product ID
0054-0272_a53a09e5-e629-45b2-9783-f5de26c056bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Capecitabine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA200483
Marketing category
ANDA
Marketing start
2016-07-15
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0054-0272-2300054027223120 TABLET, FILM COATED in 1 BOTTLE (0054-0272-23) 2016-07-150000-00-00NoNoCurrent