Abacavir and Lamivudine

Product NDC
0093-5382
11-digit product format
000935382
Labeler code
0093
Product ID
0093-5382_e4189797-7ec9-430f-a188-5fa2b35cef4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abacavir and Lamivudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA079246
Marketing category
ANDA
Marketing start
2016-09-29
Marketing end
2021-11-30
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 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
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
0093-5382-56EA - Each0093-5382b24b6a89-c9d6-4685-a09b-f13809433e1d12016-11-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-5382-56000935382561 BOTTLE in 1 CARTON (0093-5382-56) > 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-09-292021-11-30NoNoCurrent