Lamivudine and Zidovudine

Product NDC
76519-1005
11-digit product format
765191005
Labeler code
76519
Product ID
76519-1005_dae1ab04-6614-4083-b7b6-2612c4be0fe2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamivudine and Zidovudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA079081
Marketing category
ANDA
Marketing start
2011-12-27
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76519-1005-6Lamivudine and Zidovudine6 in 1 BOTTLETABLET, FILM COATED61

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76519-1005-6EA - Each76519-1005c719a330-0482-4e94-8baa-c6ea7931323112015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMIVUDINEACTIVE INGREDIENT2T8Q726O95LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
ZIDOVUDINEACTIVE INGREDIENT4B9XT59T7SLAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
LAMIVUDINEACTIVE MOIETY2T8Q726O95LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
ZIDOVUDINEACTIVE MOIETY4B9XT59T7SLAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLAMIVUDINE 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
76519-1005LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 1 package rows20120626_fc2d6065-7806-457c-82e1-04bb19e57b8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200082lamiVUDine 150 MG / zidovudine 300 MG Oral TabletPSNfc2d6065-7806-457c-82e1-04bb19e57b8c1
200082lamivudine 150 MG / zidovudine 300 MG Oral TabletSCDfc2d6065-7806-457c-82e1-04bb19e57b8c1
2000823TC 150 MG / AZT 300 MG Oral TabletSYfc2d6065-7806-457c-82e1-04bb19e57b8c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76519-1005-6765191005066 in 1 BOTTLEHistorical