Abacavir and Lamivudine

Product NDC
65862-900
11-digit product format
658620900
Labeler code
65862
Product ID
65862-900_72b6fd39-d4be-45f9-ad9c-11af12dc99b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abacavir and Lamivudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA206151
Marketing category
ANDA
Marketing start
2017-03-28
Marketing end
0000-00-00
Substance
ABACAVIR SULFATE; LAMIVUDINE
Active strength
600 mg/1; mg/1
Pharmacologic classes
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-900-30EA - Each65862-9006a025516-6cd0-434d-8665-a51c0e4c320912017-04-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-900-30658620900301 BOTTLE in 1 CARTON (65862-900-30) > 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-03-280000-00-00NoNoCurrent