FDA.reportPublic FDA data

ABACAVIR and LAMIVUDINE

Product NDC
31722-838
11-digit product format
317220838
Labeler code
31722
Product ID
31722-838_366cb4c4-0386-17b7-e063-6394a90a5fd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ABACAVIR and LAMIVUDINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA205412
Marketing category
ANDA
Marketing start
2025-04-16
Substance
ABACAVIR SULFATE; LAMIVUDINE
Active strength
600; 300 mg/1; mg/1
Pharmacologic classes
Cytochrome P450 1A1 Inhibitors [MoA], 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
ABACAVIR and LAMIVUDINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ABACAVIR SULFATE600 mg/1
LAMIVUDINE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ220T4J9Q2, 2T8Q726O95
Rxcui602393

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
e1e3cf65-28b8-ebf3-c11f-d11a82e0862aProduct name420180604
af19b329-4f44-cd81-491a-fbb7fe7a079fProduct name220151013
c873f14e-2add-4d53-b9b3-bf775efd3702Product name120150325

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-838-30ABACAVIR and LAMIVUDINE1 in 1 CARTONTABLET, FILM COATED11
31722-838-30ABACAVIR and LAMIVUDINE30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-838-30EA - Each31722-838837c1002-6ed1-4084-a7f5-9b64f9ec719512026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602393abacavir sulfate 600 MG / lamiVUDine 300 MG Oral TabletPSNe8988924-c18c-4e91-ab79-2d84e72bfa0d1
602393abacavir 600 MG / lamivudine 300 MG Oral TabletSCDe8988924-c18c-4e91-ab79-2d84e72bfa0d1
602393abacavir (as abacavir sulfate) 600 MG / lamivudine 300 MG Oral TabletSYe8988924-c18c-4e91-ab79-2d84e72bfa0d1
602393abacavir 600 MG / 3TC 300 MG Oral TabletSYe8988924-c18c-4e91-ab79-2d84e72bfa0d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-838-30317220838301 BOTTLE in 1 CARTON (31722-838-30) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2025-04-16NoNoCurrent