FDA.reportPublic FDA data

LAMIVUDINE AND ZIDOVUDINE

Product NDC
72865-144
11-digit product format
728650144
Labeler code
72865
Product ID
72865-144_f26f80c3-6ad3-2c78-e053-2995a90a7783
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamivudine and zidovudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
XLCare Pharmaceuticals, Inc
Application
ANDA203259
Marketing category
ANDA
Marketing start
2020-04-17
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LAMIVUDINE AND ZIDOVUDINE
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2T8Q726O95, 4B9XT59T7S
Rxcui200082

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
72865-144-60LAMIVUDINE AND ZIDOVUDINE60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-144-60EA - Each72865-1445d3959fe-ee7c-4bc4-9413-1a29263f503a12020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-144LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [XLCARE PHARMACEUTICALS, INC]2Current NDC, Legacy NDC, 1 package rows20230117_55520835-0f24-4e52-af8c-d65841ccaba7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200082lamiVUDine 150 MG / zidovudine 300 MG Oral TabletPSN55520835-0f24-4e52-af8c-d65841ccaba72
200082lamivudine 150 MG / zidovudine 300 MG Oral TabletSCD55520835-0f24-4e52-af8c-d65841ccaba72
2000823TC 150 MG / AZT 300 MG Oral TabletSY55520835-0f24-4e52-af8c-d65841ccaba72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72865-144-607286501446060 TABLET, FILM COATED in 1 BOTTLE (72865-144-60) 2020-04-170000-00-00NoNoCurrent