FDA.reportPublic FDA data

Lamivudine

Product NDC
33342-002
11-digit product format
333420002
Labeler code
33342
Product ID
33342-002_9e19f010-5f8a-4582-8d49-c385698d9996
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamivudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA090198
Marketing category
ANDA
Marketing start
2019-05-02
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
33342-002-07Lamivudine30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-002-07EA - Each33342-002e865e82f-e906-4b71-9276-721a2416592512019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-002LAMIVUDINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]4Current NDC, Legacy NDC, 1 package rows20221203_1be30bcc-2d9f-4afc-8f09-adc840b3f2d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199147lamiVUDine 150 MG Oral TabletPSN1be30bcc-2d9f-4afc-8f09-adc840b3f2d94
349491lamiVUDine 300 MG Oral TabletPSN1be30bcc-2d9f-4afc-8f09-adc840b3f2d94
199147lamivudine 150 MG Oral TabletSCD1be30bcc-2d9f-4afc-8f09-adc840b3f2d94
349491lamivudine 300 MG Oral TabletSCD1be30bcc-2d9f-4afc-8f09-adc840b3f2d94
1991473TC 150 MG Oral TabletSY1be30bcc-2d9f-4afc-8f09-adc840b3f2d94
3494913TC 300 MG Oral TabletSY1be30bcc-2d9f-4afc-8f09-adc840b3f2d94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
33342-002-073334200020730 TABLET, FILM COATED in 1 BOTTLE (33342-002-07) 2019-05-020000-00-00NoNoCurrent