FDA.reportPublic FDA data

COMBIVIR

Product NDC
52959-546
11-digit product format
529590546
Labeler code
52959
Product ID
52959-546_37641156-8d51-4e36-abb6-b46cb9e7f828
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamivudine and zidovudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
NDA020857
Marketing category
NDA
Marketing start
2010-10-19
Marketing end
0000-00-00
Substance
LAMIVUDINE; ZIDOVUDINE
Active strength
150 mg/1; mg/1
Pharmacologic classes
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-546-022019-11-13C16284748780-197449f38-c68f-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use COMBIVIR safely and effectively. See full prescribing information for COMBIVIR. COMBIVIR (lamivudine and zidovudine) Tablets 150 mg/300 mg Initial U.S. Approval: 1997
52959-546-032019-11-13C16284748780-197449f38-c68f-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use COMBIVIR safely and effectively. See full prescribing information for COMBIVIR. COMBIVIR (lamivudine and zidovudine) Tablets 150 mg/300 mg Initial U.S. Approval: 1997
52959-546-042019-11-13C16284748780-197449f38-c68f-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use COMBIVIR safely and effectively. See full prescribing information for COMBIVIR. COMBIVIR (lamivudine and zidovudine) Tablets 150 mg/300 mg Initial U.S. Approval: 1997
52959-546-062019-11-13C16284748780-197449f38-c68f-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use COMBIVIR safely and effectively. See full prescribing information for COMBIVIR. COMBIVIR (lamivudine and zidovudine) Tablets 150 mg/300 mg Initial U.S. Approval: 1997
52959-546-082019-11-13C16284748780-197449f38-c68f-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use COMBIVIR safely and effectively. See full prescribing information for COMBIVIR. COMBIVIR (lamivudine and zidovudine) Tablets 150 mg/300 mg Initial U.S. Approval: 1997
52959-546-102019-11-13C16284748780-197449f38-c68f-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use COMBIVIR safely and effectively. See full prescribing information for COMBIVIR. COMBIVIR (lamivudine and zidovudine) Tablets 150 mg/300 mg Initial U.S. Approval: 1997
52959-546-142019-11-13C16284748780-197449f38-c68f-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use COMBIVIR safely and effectively. See full prescribing information for COMBIVIR. COMBIVIR (lamivudine and zidovudine) Tablets 150 mg/300 mg Initial U.S. Approval: 1997
52959-546-152019-11-13C16284748780-197449f38-c68f-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use COMBIVIR safely and effectively. See full prescribing information for COMBIVIR. COMBIVIR (lamivudine and zidovudine) Tablets 150 mg/300 mg Initial U.S. Approval: 1997
52959-546-202019-11-13C16284748780-197449f38-c68f-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use COMBIVIR safely and effectively. See full prescribing information for COMBIVIR. COMBIVIR (lamivudine and zidovudine) Tablets 150 mg/300 mg Initial U.S. Approval: 1997
52959-546-282019-11-13C16284748780-197449f38-c68f-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use COMBIVIR safely and effectively. See full prescribing information for COMBIVIR. COMBIVIR (lamivudine and zidovudine) Tablets 150 mg/300 mg Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-546-02COMBIVIR2 in 1 BOTTLETABLET, FILM COATED21
52959-546-03COMBIVIR3 in 1 BOTTLETABLET, FILM COATED31
52959-546-04COMBIVIR4 in 1 BOTTLETABLET, FILM COATED41
52959-546-06COMBIVIR6 in 1 BOTTLETABLET, FILM COATED61
52959-546-08COMBIVIR8 in 1 BOTTLETABLET, FILM COATED81
52959-546-10COMBIVIR10 in 1 BOTTLETABLET, FILM COATED101
52959-546-14COMBIVIR14 in 1 BOTTLETABLET, FILM COATED141
52959-546-15COMBIVIR15 in 1 BOTTLETABLET, FILM COATED151
52959-546-20COMBIVIR20 in 1 BOTTLETABLET, FILM COATED201
52959-546-28COMBIVIR28 in 1 BOTTLETABLET, FILM COATED281

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-546-02EA - Each52959-546ba43edde-bd22-4767-8d57-304d6dc2cf5e12012-07-24
52959-546-03EA - Each52959-546d04aee2d-de2d-474a-b8d2-0aa28088d3fe12012-07-24
52959-546-04EA - Each52959-546ce4bb5e7-a00f-433b-bf21-06257055ffbd12012-07-24
52959-546-06EA - Each52959-54616fc82cd-dda4-4361-be35-4e7183045bbd12012-07-24
52959-546-08EA - Each52959-5468babc38e-6a7d-4506-940d-3b1b20ab934412012-07-24
52959-546-10EA - Each52959-546574afd53-75fa-4893-a311-2de918be33e912012-07-24
52959-546-14EA - Each52959-54669dc4852-8a85-4559-8b61-9b9b9ca8688512012-07-24
52959-546-15EA - Each52959-5460c040f7a-38e1-48ff-b641-52d347e6245512012-07-24
52959-546-20EA - Each52959-546e1eeda89-5377-49af-ba34-eb0f5ed5421112012-07-24
52959-546-28EA - Each52959-546fdd101f2-c5b9-4ba6-b379-a48df7537e2f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMIVUDINEACTIVE INGREDIENT2T8Q726O95COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
ZIDOVUDINEACTIVE INGREDIENT4B9XT59T7SCOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
LAMIVUDINEACTIVE MOIETY2T8Q726O95COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
ZIDOVUDINEACTIVE MOIETY4B9XT59T7SCOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-546COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 10 package rows20120215_479a2784-8db2-4fe5-94ba-55316a3c4e4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213088COMBIVIR 150 MG / 300 MG Oral TabletPSN479a2784-8db2-4fe5-94ba-55316a3c4e4f1
200082lamiVUDine 150 MG / zidovudine 300 MG Oral TabletPSN479a2784-8db2-4fe5-94ba-55316a3c4e4f1
213088lamivudine 150 MG / zidovudine 300 MG Oral Tablet [Combivir]SBD479a2784-8db2-4fe5-94ba-55316a3c4e4f1
200082lamivudine 150 MG / zidovudine 300 MG Oral TabletSCD479a2784-8db2-4fe5-94ba-55316a3c4e4f1
2000823TC 150 MG / AZT 300 MG Oral TabletSY479a2784-8db2-4fe5-94ba-55316a3c4e4f1
2130883TC 150 MG / AZT 300 MG Oral Tablet [Combivir]SY479a2784-8db2-4fe5-94ba-55316a3c4e4f1
213088Combivir (lamivudine 150 MG / zidovudine 300 MG) Oral TabletSY479a2784-8db2-4fe5-94ba-55316a3c4e4f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-546-02529590546022 in 1 BOTTLEHistorical
52959-546-03529590546033 in 1 BOTTLEHistorical
52959-546-04529590546044 in 1 BOTTLEHistorical
52959-546-06529590546066 in 1 BOTTLEHistorical
52959-546-08529590546088 in 1 BOTTLEHistorical
52959-546-105295905461010 in 1 BOTTLEHistorical
52959-546-145295905461414 in 1 BOTTLEHistorical
52959-546-155295905461515 in 1 BOTTLEHistorical
52959-546-205295905462020 in 1 BOTTLEHistorical
52959-546-285295905462828 in 1 BOTTLEHistorical