FDA.reportPublic FDA data

COMBIVIR

Product NDC
49702-202
11-digit product format
497020202
Labeler code
49702
Product ID
49702-202_42a6587e-9322-4810-8c72-1dc40f3543d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamivudine and zidovudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ViiV Healthcare Company
Application
NDA020857
Marketing category
NDA
Marketing start
2010-10-19
Marketing end
2027-02-28
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
COMBIVIR

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2T8Q726O95, 4B9XT59T7S
Rxcui200082, 213088

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
49702-202-18COMBIVIR60 in 1 BOTTLETABLET, FILM COATED6022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49702-202-18EA - Each49702-2028c7dcc9c-4239-4a1d-9421-3535abf9bbdd12012-07-24
49702-202-29EA - Each49702-2022723563f-4bd4-4c1e-b6fb-2711fd77464e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMIVUDINEACTIVE INGREDIENT2T8Q726O95COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10
ZIDOVUDINEACTIVE INGREDIENT4B9XT59T7SCOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10
LAMIVUDINEACTIVE MOIETY2T8Q726O95COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10
ZIDOVUDINEACTIVE MOIETY4B9XT59T7SCOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10
LAMIVUDINEACTIVE INGREDIENT2T8Q726O95COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LAMIVUDINEACTIVE INGREDIENT2T8Q726O95COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
ZIDOVUDINEACTIVE INGREDIENT4B9XT59T7SCOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]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
LAMIVUDINEACTIVE MOIETY2T8Q726O95COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ZIDOVUDINEACTIVE MOIETY4B9XT59T7SCOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
ZIDOVUDINEACTIVE MOIETY4B9XT59T7SCOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]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 [STATE OF FLORIDA DOH CENTRAL PHARMACY]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 [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]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
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]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
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49702-202COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]22Current NDC, Legacy NDC, 1 package rows20241003_16da660b-9981-4d24-a14a-94c7744fce4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213088COMBIVIR 150 MG / 300 MG Oral TabletPSN16da660b-9981-4d24-a14a-94c7744fce4f22
200082lamiVUDine 150 MG / zidovudine 300 MG Oral TabletPSN16da660b-9981-4d24-a14a-94c7744fce4f22
213088lamivudine 150 MG / zidovudine 300 MG Oral Tablet [Combivir]SBD16da660b-9981-4d24-a14a-94c7744fce4f22
200082lamivudine 150 MG / zidovudine 300 MG Oral TabletSCD16da660b-9981-4d24-a14a-94c7744fce4f22
2000823TC 150 MG / AZT 300 MG Oral TabletSY16da660b-9981-4d24-a14a-94c7744fce4f22
2130883TC 150 MG / AZT 300 MG Oral Tablet [Combivir]SY16da660b-9981-4d24-a14a-94c7744fce4f22
213088Combivir (lamivudine 150 MG / zidovudine 300 MG) Oral TabletSY16da660b-9981-4d24-a14a-94c7744fce4f22
213088COMBIVIR 150 MG / 300 MG Oral TabletPSN479a2784-8db2-4fe5-94ba-55316a3c4e4f1
213088COMBIVIR 150 MG / 300 MG Oral TabletPSN1bc4c6c8-7e75-494e-810b-8f83135a32041
200082lamiVUDine 150 MG / zidovudine 300 MG Oral TabletPSN1bc4c6c8-7e75-494e-810b-8f83135a32041
200082lamiVUDine 150 MG / zidovudine 300 MG Oral TabletPSN479a2784-8db2-4fe5-94ba-55316a3c4e4f1
213088lamivudine 150 MG / zidovudine 300 MG Oral Tablet [Combivir]SBD1bc4c6c8-7e75-494e-810b-8f83135a32041
213088lamivudine 150 MG / zidovudine 300 MG Oral Tablet [Combivir]SBD479a2784-8db2-4fe5-94ba-55316a3c4e4f1
200082lamivudine 150 MG / zidovudine 300 MG Oral TabletSCD1bc4c6c8-7e75-494e-810b-8f83135a32041
200082lamivudine 150 MG / zidovudine 300 MG Oral TabletSCD479a2784-8db2-4fe5-94ba-55316a3c4e4f1
2000823TC 150 MG / AZT 300 MG Oral TabletSY1bc4c6c8-7e75-494e-810b-8f83135a32041
2000823TC 150 MG / AZT 300 MG Oral TabletSY479a2784-8db2-4fe5-94ba-55316a3c4e4f1
2130883TC 150 MG / AZT 300 MG Oral Tablet [Combivir]SY1bc4c6c8-7e75-494e-810b-8f83135a32041
2130883TC 150 MG / AZT 300 MG Oral Tablet [Combivir]SY479a2784-8db2-4fe5-94ba-55316a3c4e4f1
213088Combivir (lamivudine 150 MG / zidovudine 300 MG) Oral TabletSY1bc4c6c8-7e75-494e-810b-8f83135a32041
213088Combivir (lamivudine 150 MG / zidovudine 300 MG) Oral TabletSY479a2784-8db2-4fe5-94ba-55316a3c4e4f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49702-202-184970202021860 TABLET, FILM COATED in 1 BOTTLE (49702-202-18) 2010-10-192027-02-28NoNoCurrent