FDA.reportPublic FDA data

lamivudine

Product NDC
62135-706
11-digit product format
621350706
Labeler code
62135
Product ID
62135-706_472f29d3-cf7e-0a76-e063-6294a90a9e7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamivudine oral
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA203564
Marketing category
ANDA
Marketing start
2014-10-31
Substance
LAMIVUDINE
Active strength
10 mg/mL
Pharmacologic classes
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMIVUDINE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2T8Q726O95
Rxcui199148

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-706-24lamivudine2 in 1 BOXSOLUTION23
62135-706-24lamivudine10 in 1 TRAYSOLUTION103
62135-706-30lamivudine30 mL in 1 CUPSOLUTION303
62135-706-37lamivudine240 mL in 1 BOTTLE, PLASTICSOLUTION2403

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-706-24ML - Milliliter62135-7063e0b6e10-62b3-4c36-a22d-69600a55e2b312025-05-14
62135-706-30ML - Milliliter62135-706c030a2ff-4e9b-408b-9fea-6117774d893b12025-05-14
62135-706-37ML - Milliliter62135-706418934d8-97f6-419b-85ca-318946226d6512023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-706LAMIVUDINE (LAMIVUDINE ORAL) SOLUTION [CHARTWELL RX, LLC]2Current NDC, 4 package rows20250312_ef9977cb-ec91-46d7-b769-d26decfd6fe7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199148lamiVUDine 10 MG in 1 mL Oral SolutionPSNef9977cb-ec91-46d7-b769-d26decfd6fe73
199148lamivudine 10 MG/ML Oral SolutionSCDef9977cb-ec91-46d7-b769-d26decfd6fe73
1991483TC 10 MG/ML Oral SolutionSYef9977cb-ec91-46d7-b769-d26decfd6fe73
199148lamivudine 10 MG per 1 ML Oral SolutionSYef9977cb-ec91-46d7-b769-d26decfd6fe73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-706-24621350706242 TRAY in 1 BOX (62135-706-24) / 10 CUP in 1 TRAY / 30 mL in 1 CUP (62135-706-30) 2 tray2025-03-06NoNoCurrent
62135-706-306213507063030 mL in 1 CUP30 mlHistorical
62135-706-3762135070637240 mL in 1 BOTTLE, PLASTIC (62135-706-37) 240 ml2023-07-20NoNoCurrent