FDA.reportPublic FDA data

LAMIVUDINE

Product NDC
60505-3252
11-digit product format
605053252
Labeler code
60505
Product ID
60505-3252_2cca5476-aba6-0525-0bb5-890f2ca25bb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamivudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA091606
Marketing category
ANDA
Marketing start
2011-12-02
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
LAMIVUDINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMIVUDINE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2T8Q726O95
Rxcui199147, 349491

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
60505-3252-3LAMIVUDINE30 in 1 BOTTLETABLET, FILM COATED3026
60505-3252-8LAMIVUDINE1000 in 1 BOTTLETABLET, FILM COATED100026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3252-3EA - Each60505-325216a94c98-86d1-4cbb-9738-e16cac8ad81e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMIVUDINEACTIVE INGREDIENT2T8Q726O95LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]15
LAMIVUDINEACTIVE MOIETY2T8Q726O95LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]15
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]15
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]15
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]15
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]15
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PLAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]15
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]15
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]15
LAMIVUDINEACTIVE INGREDIENT2T8Q726O95LAMIVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LAMIVUDINEACTIVE INGREDIENT2T8Q726O95LAMIVUDINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
LAMIVUDINEACTIVE MOIETY2T8Q726O95LAMIVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LAMIVUDINEACTIVE MOIETY2T8Q726O95LAMIVUDINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLAMIVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLAMIVUDINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LAMIVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLAMIVUDINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLAMIVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LAMIVUDINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LAMIVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PLAMIVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PLAMIVUDINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLAMIVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLAMIVUDINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMIVUDINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMIVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALAMIVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALAMIVUDINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LAMIVUDINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLAMIVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLAMIVUDINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-3252LAMIVUDINE TABLET, FILM COATED [APOTEX CORP.]25Current NDC, Legacy NDC, 2 package rows20240927_34c02bcc-d6ff-99d4-8e6a-4a91908adca8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199147lamiVUDine 150 MG Oral TabletPSN34c02bcc-d6ff-99d4-8e6a-4a91908adca826
349491lamiVUDine 300 MG Oral TabletPSN34c02bcc-d6ff-99d4-8e6a-4a91908adca826
199147lamivudine 150 MG Oral TabletSCD34c02bcc-d6ff-99d4-8e6a-4a91908adca826
349491lamivudine 300 MG Oral TabletSCD34c02bcc-d6ff-99d4-8e6a-4a91908adca826
1991473TC 150 MG Oral TabletSY34c02bcc-d6ff-99d4-8e6a-4a91908adca826
3494913TC 300 MG Oral TabletSY34c02bcc-d6ff-99d4-8e6a-4a91908adca826
199147lamiVUDine 150 MG Oral TabletPSNf3637209-303e-4232-ae79-07315a9909739
349491lamiVUDine 300 MG Oral TabletPSNf3637209-303e-4232-ae79-07315a9909739
199147lamivudine 150 MG Oral TabletSCDf3637209-303e-4232-ae79-07315a9909739
349491lamivudine 300 MG Oral TabletSCDf3637209-303e-4232-ae79-07315a9909739
1991473TC 150 MG Oral TabletSYf3637209-303e-4232-ae79-07315a9909739
3494913TC 300 MG Oral TabletSYf3637209-303e-4232-ae79-07315a9909739
199147lamiVUDine 150 MG Oral TabletPSN26182670-f400-49b8-92e7-f0124920af781
349491lamiVUDine 300 MG Oral TabletPSN26182670-f400-49b8-92e7-f0124920af781
199147lamivudine 150 MG Oral TabletSCD26182670-f400-49b8-92e7-f0124920af781
349491lamivudine 300 MG Oral TabletSCD26182670-f400-49b8-92e7-f0124920af781
1991473TC 150 MG Oral TabletSY26182670-f400-49b8-92e7-f0124920af781
3494913TC 300 MG Oral TabletSY26182670-f400-49b8-92e7-f0124920af781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-3252-36050532520330 TABLET, FILM COATED in 1 BOTTLE (60505-3252-3) 2011-12-020000-00-00NoNoCurrent
60505-3252-8605053252081000 TABLET, FILM COATED in 1 BOTTLE (60505-3252-8) 2011-12-020000-00-00NoNoCurrent