EPIVIR

Product NDC
53808-0893
11-digit product format
538080893
Labeler code
53808
Product ID
53808-0893_50cf8e19-72f4-4202-895f-cc9f81c2ca6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamivudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA021003
Marketing category
NDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
LAMIVUDINE
Active strength
100 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]
NDC exclude flag
No
Listing certified through
2019-12-31
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
af19b329-4f44-cd81-491a-fbb7fe7a079fProduct name220151013
c873f14e-2add-4d53-b9b3-bf775efd3702Product name120150325

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0893-1EPIVIRHBV30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMIVUDINEACTIVE INGREDIENT2T8Q726O95EPIVIR HBV (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LAMIVUDINEACTIVE MOIETY2T8Q726O95EPIVIR HBV (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEPIVIR HBV (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675EPIVIR HBV (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTEPIVIR HBV (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEPIVIR HBV (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EPIVIR HBV (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEPIVIR HBV (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HEPIVIR HBV (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2EPIVIR HBV (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEPIVIR HBV (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0893EPIVIR HBV (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20141007_83009c27-f54b-47df-b8b2-e2e4e0b8f4e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213483Epivir-HBV 100 MG Oral TabletPSN83009c27-f54b-47df-b8b2-e2e4e0b8f4e81
205328lamiVUDine 100 MG Oral TabletPSN83009c27-f54b-47df-b8b2-e2e4e0b8f4e81
213483lamivudine 100 MG Oral Tablet [Epivir HBV]SBD83009c27-f54b-47df-b8b2-e2e4e0b8f4e81
205328lamivudine 100 MG Oral TabletSCD83009c27-f54b-47df-b8b2-e2e4e0b8f4e81
2053283TC 100 MG Oral TabletSY83009c27-f54b-47df-b8b2-e2e4e0b8f4e81
2134833TC 100 MG Oral Tablet [Epivir HBV]SY83009c27-f54b-47df-b8b2-e2e4e0b8f4e81
213483Epivir HBV 100 MG Oral TabletSY83009c27-f54b-47df-b8b2-e2e4e0b8f4e81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0893-15380808930130 in 1 BLISTER PACKHistorical