LAMIVUDINE and ZIDOVUDINE

Product NDC
71335-0639
11-digit product format
713350639
Labeler code
71335
Product ID
71335-0639_aa348cf2-2e1b-486f-9bec-5ccf67879175
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LAMIVUDINE and ZIDOVUDINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA079124
Marketing category
ANDA
Marketing start
2015-09-18
Substance
LAMIVUDINE; ZIDOVUDINE
Active strength
150; 300 mg/1; mg/1
Pharmacologic classes
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], 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 and ZIDOVUDINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMIVUDINE150 mg/1
ZIDOVUDINE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2T8Q726O95, 4B9XT59T7S
Rxcui200082

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
e1098f43-eafb-82a0-ef30-575f1d8189b0Product name220150227
9ceb457b-0c09-9326-bbca-f296202d412cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0639-1LAMIVUDINE and ZIDOVUDINE6 in 1 BOTTLETABLET, FILM COATED65
71335-0639-2LAMIVUDINE and ZIDOVUDINE60 in 1 BOTTLETABLET, FILM COATED605
71335-0639-3LAMIVUDINE and ZIDOVUDINE4 in 1 BOTTLETABLET, FILM COATED45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0639LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 3 package rows20230331_005f1b9d-1950-4ef3-a9d6-c428a40a3630.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200082lamiVUDine 150 MG / zidovudine 300 MG Oral TabletPSN005f1b9d-1950-4ef3-a9d6-c428a40a36305
200082lamivudine 150 MG / zidovudine 300 MG Oral TabletSCD005f1b9d-1950-4ef3-a9d6-c428a40a36305
2000823TC 150 MG / AZT 300 MG Oral TabletSY005f1b9d-1950-4ef3-a9d6-c428a40a36305

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0639-1713350639016 TABLET, FILM COATED in 1 BOTTLE (71335-0639-1) 2021-04-020000-00-00NoNoCurrent
71335-0639-27133506390260 TABLET, FILM COATED in 1 BOTTLE (71335-0639-2) 2021-12-270000-00-00NoNoCurrent
71335-0639-3713350639034 TABLET, FILM COATED in 1 BOTTLE (71335-0639-3) 2021-12-270000-00-00NoNoCurrent