Lamivudine

Product NDC
66993-478
11-digit product format
669930478
Labeler code
66993
Product ID
66993-478_40ed96c7-84aa-44ac-be68-74b0b8a62b9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamivudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Prasco Laboratories
Application
NDA021003
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-09-05
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 Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-478-60EA - Each66993-478803a04fd-e267-4bc2-a2e8-52e44d33287212014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMIVUDINEACTIVE INGREDIENT2T8Q726O95LAMIVUDINE TABLET, FILM COATED [PRASCO LABORATORIES]2
LAMIVUDINEACTIVE MOIETY2T8Q726O95LAMIVUDINE TABLET, FILM COATED [PRASCO LABORATORIES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMIVUDINE TABLET, FILM COATED [PRASCO LABORATORIES]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LAMIVUDINE TABLET, FILM COATED [PRASCO LABORATORIES]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLAMIVUDINE TABLET, FILM COATED [PRASCO LABORATORIES]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLAMIVUDINE TABLET, FILM COATED [PRASCO LABORATORIES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMIVUDINE TABLET, FILM COATED [PRASCO LABORATORIES]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALAMIVUDINE TABLET, FILM COATED [PRASCO LABORATORIES]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLAMIVUDINE TABLET, FILM COATED [PRASCO LABORATORIES]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMIVUDINE TABLET, FILM COATED [PRASCO LABORATORIES]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLAMIVUDINE TABLET, FILM COATED [PRASCO LABORATORIES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-478LAMIVUDINE TABLET, FILM COATED [PRASCO LABORATORIES]13Legacy NDC20241220_a5b963ec-b139-4e28-b447-b72c9e710c1f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66993-478-606699304786060 TABLET, FILM COATED in 1 BOTTLE (66993-478-60) 2014-09-050000-00-00NoNoCurrent