COMBIVIR

Product NDC
53808-0895
11-digit product format
538080895
Labeler code
53808
Product ID
53808-0895_30dbb679-87a4-4823-b61b-f4b9d8078955
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamivudine and zidovudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA020857
Marketing category
NDA
Marketing start
2014-01-01
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
No
Listing certified through
2019-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0895-1COMBIVIR30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMIVUDINEACTIVE INGREDIENT2T8Q726O95COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ZIDOVUDINEACTIVE INGREDIENT4B9XT59T7SCOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LAMIVUDINEACTIVE MOIETY2T8Q726O95COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]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
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCOMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]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 [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
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
53808-0895COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20141118_1bc4c6c8-7e75-494e-810b-8f83135a3204.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213088COMBIVIR 150 MG / 300 MG Oral TabletPSN1bc4c6c8-7e75-494e-810b-8f83135a32041
200082lamiVUDine 150 MG / zidovudine 300 MG Oral TabletPSN1bc4c6c8-7e75-494e-810b-8f83135a32041
213088lamivudine 150 MG / zidovudine 300 MG Oral Tablet [Combivir]SBD1bc4c6c8-7e75-494e-810b-8f83135a32041
200082lamivudine 150 MG / zidovudine 300 MG Oral TabletSCD1bc4c6c8-7e75-494e-810b-8f83135a32041
2000823TC 150 MG / AZT 300 MG Oral TabletSY1bc4c6c8-7e75-494e-810b-8f83135a32041
2130883TC 150 MG / AZT 300 MG Oral Tablet [Combivir]SY1bc4c6c8-7e75-494e-810b-8f83135a32041
213088Combivir (lamivudine 150 MG / zidovudine 300 MG) Oral TabletSY1bc4c6c8-7e75-494e-810b-8f83135a32041

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0895-15380808950130 in 1 BLISTER PACKHistorical