FDA.reportPublic FDA data

Abacavir

Product NDC
31722-557
11-digit product format
317220557
Labeler code
31722
Product ID
31722-557_2b451c79-7df8-d0f9-e063-6294a90a5fcf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abacavir
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA091560
Marketing category
ANDA
Marketing start
2021-04-01
Substance
ABACAVIR SULFATE
Active strength
300 mg/1
Pharmacologic classes
Cytochrome P450 1A1 Inhibitors [MoA], 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
Abacavir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ABACAVIR SULFATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ220T4J9Q2
Rxcui242679

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
aaa99659-c62c-7281-d402-9590409850c2Product name620260128
3832141c-c294-474a-9473-1052c891450eProduct name220230105
e1e3cf65-28b8-ebf3-c11f-d11a82e0862aProduct name420180604
af19b329-4f44-cd81-491a-fbb7fe7a079fProduct name220151013

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-557-60Abacavir60 in 1 BOTTLETABLET606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-557-60EA - Each31722-55778058bfb-1699-4ca0-8cf2-8dcda69917f612014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ABACAVIR SULFATEACTIVE INGREDIENTJ220T4J9Q2ABACAVIR TABLET [CAMBER PHARMACEUTICALS, INC.]2
ABACAVIRACTIVE MOIETYWR2TIP26VSABACAVIR TABLET [CAMBER PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UABACAVIR TABLET [CAMBER PHARMACEUTICALS, INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ABACAVIR TABLET [CAMBER PHARMACEUTICALS, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTABACAVIR TABLET [CAMBER PHARMACEUTICALS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOABACAVIR TABLET [CAMBER PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ABACAVIR TABLET [CAMBER PHARMACEUTICALS, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HABACAVIR TABLET [CAMBER PHARMACEUTICALS, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ABACAVIR TABLET [CAMBER PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPABACAVIR TABLET [CAMBER PHARMACEUTICALS, INC.]2
TRIACETININACTIVE INGREDIENTXHX3C3X673ABACAVIR TABLET [CAMBER PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-557ABACAVIR (ABACAVIR) TABLET [CAMBER PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 1 package rows20250112_44fb1e25-ad03-4a7f-9f35-2e29f5025661.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242679abacavir 300 MG Oral TabletPSN44fb1e25-ad03-4a7f-9f35-2e29f50256616
242679abacavir 300 MG Oral TabletSCD44fb1e25-ad03-4a7f-9f35-2e29f50256616
242679abacavir (as abacavir sulfate) 300 MG Oral TabletSY44fb1e25-ad03-4a7f-9f35-2e29f50256616
242679abacavir 300 MG Oral TabletPSNa2f06528-f3c5-2466-e053-2995a90ae18a4
242679abacavir 300 MG Oral TabletSCDa2f06528-f3c5-2466-e053-2995a90ae18a4
242679abacavir (as abacavir sulfate) 300 MG Oral TabletSYa2f06528-f3c5-2466-e053-2995a90ae18a4
242679abacavir 300 MG Oral TabletPSN42ca758a-1694-c614-e063-6294a90a8c7e2
242679abacavir 300 MG Oral TabletSCD42ca758a-1694-c614-e063-6294a90a8c7e2
242679abacavir (as abacavir sulfate) 300 MG Oral TabletSY42ca758a-1694-c614-e063-6294a90a8c7e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-557-603172205576060 TABLET in 1 BOTTLE (31722-557-60) 60 tablet2021-04-010000-00-00NoNoCurrent