FDA.reportPublic FDA data

EPIVIR

Product NDC
49702-204
11-digit product format
497020204
Labeler code
49702
Product ID
49702-204_3d326658-e562-4d27-a0ad-ca2017db2e49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamivudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ViiV Healthcare Company
Application
NDA020564
Marketing category
NDA
Marketing start
2010-10-04
Substance
LAMIVUDINE
Active strength
300 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
EPIVIR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMIVUDINE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2T8Q726O95
Rxcui152931, 152932, 199147, 199148, 349491, 352230

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49702-204-132023-02-02C16284748780-1f386c64a-3e61-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use EPIVIR safely and effectively. See full prescribing information for EPIVIR. EPIVIR (lamivudine) tablets, for oral use EPIVIR (lamivudine) oral solution Initial U.S. Approval: 1995
49702-204-132023-01-30C16284748780-1f386c64a-3e61-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use EPIVIR safely and effectively. See full prescribing information for EPIVIR. EPIVIR (lamivudine) tablets, for oral use EPIVIR (lamivudine) oral solution Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49702-204-13EPIVIR30 in 1 BOTTLETABLET, FILM COATED3023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49702-204-13EA - Each49702-204de55e434-cc7b-4bbc-b81d-3e3e76eedfcd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMIVUDINEACTIVE INGREDIENT2T8Q726O95EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY]11
LAMIVUDINEACTIVE MOIETY2T8Q726O95EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY]11
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLEPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY]11
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY]11
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY]11
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TEPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY]11
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY]11
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HEPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY]11
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY]11
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHEPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY]11
SUCROSEINACTIVE INGREDIENTC151H8M554EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY]11
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KEPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49702-204EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY]22Current NDC, Legacy NDC, 1 package rows20241017_89226149-47fa-4f7d-bb1f-1aa7034486b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152932EPIVIR 10 MG in 1 mL Oral SolutionPSN89226149-47fa-4f7d-bb1f-1aa7034486b823
152931Epivir 150 MG Oral TabletPSN89226149-47fa-4f7d-bb1f-1aa7034486b823
352230Epivir 300 MG Oral TabletPSN89226149-47fa-4f7d-bb1f-1aa7034486b823
199148lamiVUDine 10 MG in 1 mL Oral SolutionPSN89226149-47fa-4f7d-bb1f-1aa7034486b823
199147lamiVUDine 150 MG Oral TabletPSN89226149-47fa-4f7d-bb1f-1aa7034486b823
349491lamiVUDine 300 MG Oral TabletPSN89226149-47fa-4f7d-bb1f-1aa7034486b823
152932lamivudine 10 MG/ML Oral Solution [Epivir]SBD89226149-47fa-4f7d-bb1f-1aa7034486b823
152931lamivudine 150 MG Oral Tablet [Epivir]SBD89226149-47fa-4f7d-bb1f-1aa7034486b823
352230lamivudine 300 MG Oral Tablet [Epivir]SBD89226149-47fa-4f7d-bb1f-1aa7034486b823
199148lamivudine 10 MG/ML Oral SolutionSCD89226149-47fa-4f7d-bb1f-1aa7034486b823
199147lamivudine 150 MG Oral TabletSCD89226149-47fa-4f7d-bb1f-1aa7034486b823
349491lamivudine 300 MG Oral TabletSCD89226149-47fa-4f7d-bb1f-1aa7034486b823
1991483TC 10 MG/ML Oral SolutionSY89226149-47fa-4f7d-bb1f-1aa7034486b823
1529323TC 10 MG/ML Oral Solution [Epivir]SY89226149-47fa-4f7d-bb1f-1aa7034486b823
1991473TC 150 MG Oral TabletSY89226149-47fa-4f7d-bb1f-1aa7034486b823
1529313TC 150 MG Oral Tablet [Epivir]SY89226149-47fa-4f7d-bb1f-1aa7034486b823
3494913TC 300 MG Oral TabletSY89226149-47fa-4f7d-bb1f-1aa7034486b823
3522303TC 300 MG Oral Tablet [Epivir]SY89226149-47fa-4f7d-bb1f-1aa7034486b823
152932Epivir 10 MG per 1 ML Oral SolutionSY89226149-47fa-4f7d-bb1f-1aa7034486b823
152931Epivir 150 MG Oral TabletSY89226149-47fa-4f7d-bb1f-1aa7034486b823
352230Epivir 300 MG Oral TabletSY89226149-47fa-4f7d-bb1f-1aa7034486b823
199148lamivudine 10 MG per 1 ML Oral SolutionSY89226149-47fa-4f7d-bb1f-1aa7034486b823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49702-204-134970202041330 TABLET, FILM COATED in 1 BOTTLE (49702-204-13) 2010-10-040000-00-00NoNoCurrent