FDA.reportPublic FDA data

COMBIVIR

Product NDC
21695-846
11-digit product format
216950846
Labeler code
21695
Product ID
21695-846_d8540843-055c-47fb-9cff-81e64b1d41c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamivudine and zidovudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA020857
Marketing category
NDA
Marketing start
1997-09-30
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
21695-846-062019-09-24C16284748780-1934fe258-48c0-48b1-e053-8cdaa90a720aThese 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
21695-846-06COMBIVIR6 in 1 BOTTLETABLET, FILM COATED61

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-846-06EA - Each21695-8465b90c26d-32ea-43f4-aa3c-fcb46eb652f812012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-846COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20101126_d8540843-055c-47fb-9cff-81e64b1d41c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213088COMBIVIR 150 MG / 300 MG Oral TabletPSNd8540843-055c-47fb-9cff-81e64b1d41c31
200082lamiVUDine 150 MG / zidovudine 300 MG Oral TabletPSNd8540843-055c-47fb-9cff-81e64b1d41c31
213088lamivudine 150 MG / zidovudine 300 MG Oral Tablet [Combivir]SBDd8540843-055c-47fb-9cff-81e64b1d41c31
200082lamivudine 150 MG / zidovudine 300 MG Oral TabletSCDd8540843-055c-47fb-9cff-81e64b1d41c31
2000823TC 150 MG / AZT 300 MG Oral TabletSYd8540843-055c-47fb-9cff-81e64b1d41c31
2130883TC 150 MG / AZT 300 MG Oral Tablet [Combivir]SYd8540843-055c-47fb-9cff-81e64b1d41c31
213088Combivir (lamivudine 150 MG / zidovudine 300 MG) Oral TabletSYd8540843-055c-47fb-9cff-81e64b1d41c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-846-06216950846066 in 1 BOTTLEHistorical