FDA.reportPublic FDA data

Abacavir

Product NDC
65862-073
11-digit product format
658620073
Labeler code
65862
Product ID
65862-073_6aae2ecb-8c31-48c8-9e6d-6b41c5ab4da4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abacavir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA077844
Marketing category
ANDA
Marketing start
2012-12-17
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
65862-073-60Abacavir60 in 1 BOTTLETABLET, FILM COATED6016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-073-60EA - Each65862-0730230c533-6540-4dc1-9101-f6fe540d57bc12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ABACAVIR SULFATEACTIVE INGREDIENTJ220T4J9Q2ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
ABACAVIRACTIVE MOIETYWR2TIP26VSABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
TRIACETININACTIVE INGREDIENTXHX3C3X673ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
ABACAVIR SULFATEACTIVE INGREDIENTJ220T4J9Q2ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
ABACAVIRACTIVE MOIETYWR2TIP26VSABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
TRIACETININACTIVE INGREDIENTXHX3C3X673ABACAVIR (ABACAVIR SULFATE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-073ABACAVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]16Current NDC, Legacy NDC, 1 package rows20240507_5409c8ed-17c3-454f-bb88-d597ba8f84ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242679abacavir 300 MG Oral TabletPSN5409c8ed-17c3-454f-bb88-d597ba8f84ec16
242679abacavir 300 MG Oral TabletSCD5409c8ed-17c3-454f-bb88-d597ba8f84ec16
242679abacavir (as abacavir sulfate) 300 MG Oral TabletSY5409c8ed-17c3-454f-bb88-d597ba8f84ec16
242679abacavir 300 MG Oral TabletPSN01e46f58-8bda-4ff3-ab21-57d5b540d4407
242679abacavir 300 MG Oral TabletSCD01e46f58-8bda-4ff3-ab21-57d5b540d4407
242679abacavir (as abacavir sulfate) 300 MG Oral TabletSY01e46f58-8bda-4ff3-ab21-57d5b540d4407
242679abacavir 300 MG Oral TabletPSN4b286ec6-68a7-4ec0-af07-5a27ec9cb35d6
242679abacavir 300 MG Oral TabletSCD4b286ec6-68a7-4ec0-af07-5a27ec9cb35d6
242679abacavir (as abacavir sulfate) 300 MG Oral TabletSY4b286ec6-68a7-4ec0-af07-5a27ec9cb35d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-073-606586200736060 TABLET, FILM COATED in 1 BOTTLE (65862-073-60) 2012-12-170000-00-00NoNoCurrent