EPZICOM

Product NDC
49702-206
11-digit product format
497020206
Labeler code
49702
Product ID
49702-206_532f9480-523b-49ed-8df1-1aa4317706c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
abacavir sulfate and lamivudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ViiV Healthcare Company
Application
NDA021652
Marketing category
NDA
Marketing start
2010-10-12
Marketing end
0000-00-00
Substance
ABACAVIR SULFATE; LAMIVUDINE
Active strength
600 mg/1; mg/1
Pharmacologic classes
Cytochrome P450 1A1 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49702-206-13EA - Each49702-2062c2b5cc5-e73d-4c42-bd69-6ec9841e885012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ABACAVIR SULFATEACTIVE INGREDIENTJ220T4J9Q2EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]15
LAMIVUDINEACTIVE INGREDIENT2T8Q726O95EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]15
ABACAVIRACTIVE MOIETYWR2TIP26VSEPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]15
LAMIVUDINEACTIVE MOIETY2T8Q726O95EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]15
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]15
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]15
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQEPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]15
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HEPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]15
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49702-206EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]29Legacy NDC20240615_f1139e7f-2db9-4961-9da3-9b7f2088736f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49702-206-134970202061330 TABLET, FILM COATED in 1 BOTTLE (49702-206-13) 2010-10-120000-00-00NoNoCurrent