Epzicom

Product NDC

49349-701

11-digit product format

493490701

Labeler code

49349

Product ID

49349-701_d9d63875-a435-479f-ae39-e83ad7462d93

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Abacavir Sulfate and Lamivudine

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

REMEDYREPACK INC.

Application

NDA021652

Marketing category

NDA

Marketing start

2011-09-12

Marketing end

0000-00-00

Substance

ABACAVIR SULFATE; LAMIVUDINE

Active strength

600 mg/1; mg/1

Pharmacologic classes

Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],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]

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record