FDA.reportPublic FDA data

Lamivudine

Product NDC
60505-3250
11-digit product format
605053250
Labeler code
60505
Product ID
60505-3250_57b50cc9-4140-66b7-ec3c-e10a213dae03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamivudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA202941
Marketing category
ANDA
Marketing start
2014-01-03
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMIVUDINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2T8Q726O95
Rxcui205328

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-3250-6Lamivudine60 in 1 BOTTLETABLET, FILM COATED6011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3250-6EA - Each60505-3250e310c39f-799a-48a2-8f99-7a6401949b8012014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMIVUDINEACTIVE INGREDIENT2T8Q726O95LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]2
LAMIVUDINEACTIVE MOIETY2T8Q726O95LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PLAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-3250LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]10Current NDC, Legacy NDC, 1 package rows20240927_87095352-c088-74b1-7be0-d3e293a90611.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205328lamiVUDine 100 MG Oral TabletPSN87095352-c088-74b1-7be0-d3e293a9061111
205328lamivudine 100 MG Oral TabletSCD87095352-c088-74b1-7be0-d3e293a9061111
2053283TC 100 MG Oral TabletSY87095352-c088-74b1-7be0-d3e293a9061111
205328lamiVUDine 100 MG Oral TabletPSN3c30216d-f9f5-104b-e063-6294a90af8fd1
205328lamivudine 100 MG Oral TabletSCD3c30216d-f9f5-104b-e063-6294a90af8fd1
2053283TC 100 MG Oral TabletSY3c30216d-f9f5-104b-e063-6294a90af8fd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-3250-66050532500660 TABLET, FILM COATED in 1 BOTTLE (60505-3250-6) 2014-01-030000-00-00NoNoCurrent