EPZICOM

Product NDC
53808-0767
11-digit product format
538080767
Labeler code
53808
Product ID
53808-0767_74505e7d-79df-4432-83b4-dc03d441e0cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
abacavir sulfate and lamivudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA021652
Marketing category
NDA
Marketing start
2009-07-01
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
aaa99659-c62c-7281-d402-9590409850c2Product name620260128
a02e6d35-8cc4-a80a-fd4d-d3ec16f69b8eProduct name820250626
4ef90d80-1289-4267-a2bb-01c741d1208fProduct name120230829
72dcca4e-6eae-4149-a92b-264c2a07004fProduct name120230808
3832141c-c294-474a-9473-1052c891450eProduct name220230105
320f244d-8b4e-4893-9f14-104b2a8e0aafProduct name220201007
7ff71f22-5b66-4a3d-bf64-671893a6409dProduct name220201007
3644e9cf-6f4d-4b63-b875-6a4b5187c47eProduct name120190703
0e579b5c-f0b5-e690-466e-4a5e809e2c68Product name320190627
6f122144-2ceb-48fa-a906-0d2eb742717eProduct name120190624
8051c8a3-aee0-45a2-a236-8ee3f9e65f67Product name120181211
fbdbfbef-2c33-0298-4fef-f6693e670fe1Product name720181210
d07e0b9e-e041-41dc-942a-a2a6601dc221Product name120181029
e1e3cf65-28b8-ebf3-c11f-d11a82e0862aProduct name420180604
af19b329-4f44-cd81-491a-fbb7fe7a079fProduct name220151013
c873f14e-2add-4d53-b9b3-bf775efd3702Product name120150325

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0767-12019-10-21C16284748780-1956f9ecf-cab0-621f-e053-dbdaa90a74adEPZICOM ® (abacavir sulfate and lamivudine) Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0767-1EPZICOM30 in 1 BLISTER PACKTABLET, FILM COATED302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ABACAVIR SULFATEACTIVE INGREDIENTJ220T4J9Q2EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
LAMIVUDINEACTIVE INGREDIENT2T8Q726O95EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
ABACAVIRACTIVE MOIETYWR2TIP26VSEPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
LAMIVUDINEACTIVE MOIETY2T8Q726O95EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOEPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQEPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HEPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0767EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2Legacy NDC, 1 package rows20100809_e0fc8605-1d64-41ab-af7e-bcf66a57c1fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602393abacavir sulfate 600 MG / lamiVUDine 300 MG Oral TabletPSNe0fc8605-1d64-41ab-af7e-bcf66a57c1fd2
602395EPZICOM 600 MG / 300 MG Oral TabletPSNe0fc8605-1d64-41ab-af7e-bcf66a57c1fd2
602395abacavir 600 MG / lamivudine 300 MG Oral Tablet [Epzicom]SBDe0fc8605-1d64-41ab-af7e-bcf66a57c1fd2
602393abacavir 600 MG / lamivudine 300 MG Oral TabletSCDe0fc8605-1d64-41ab-af7e-bcf66a57c1fd2
602393abacavir (as abacavir sulfate) 600 MG / lamivudine 300 MG Oral TabletSYe0fc8605-1d64-41ab-af7e-bcf66a57c1fd2
602393abacavir 600 MG / 3TC 300 MG Oral TabletSYe0fc8605-1d64-41ab-af7e-bcf66a57c1fd2
602395abacavir 600 MG / 3TC 300 MG Oral Tablet [Epzicom]SYe0fc8605-1d64-41ab-af7e-bcf66a57c1fd2
602395Epzicom (abacavir 600 MG / lamivudine 300 MG) Oral TabletSYe0fc8605-1d64-41ab-af7e-bcf66a57c1fd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0767-15380807670130 in 1 BLISTER PACKHistorical