Capecitabine

Product NDC
65162-844
11-digit product format
651620844
Labeler code
65162
Product ID
65162-844_76650027-01fc-4ee0-beef-7db5513355c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Capecitabine
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA204741
Marketing category
ANDA
Marketing start
2017-03-10
Marketing end
2024-02-01
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-844-16EA - Each65162-844a204d7d5-c5b6-4277-83e6-459de81fd7e712017-04-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-844-066516208440660 TABLET in 1 BOTTLE (65162-844-06) 60 tablet2017-03-100000-00-00NoNoCurrent
65162-844-1665162084416120 TABLET in 1 BOTTLE (65162-844-16) 120 tablet2017-03-100000-00-00NoNoCurrent
65162-844-5065162084450500 TABLET in 1 BOTTLE (65162-844-50) 500 tablet2017-03-100000-00-00NoNoCurrent