FDA.reportPublic FDA data

Abacavir Sulfate

Product NDC
0378-4105
11-digit product format
003784105
Labeler code
0378
Product ID
0378-4105_3ae56d4c-73b4-497f-bc93-554a247f2359
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
abacavir sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA091294
Marketing category
ANDA
Marketing start
2012-06-19
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 Sulfate
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
0378-4105-91Abacavir Sulfate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6012
0378-4105-91Abacavir Sulfate1 in 1 CARTONTABLET, FILM COATED112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-4105-91EA - Each0378-4105c5bc4af6-ec34-4bd3-a82d-b82432c45ea812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ABACAVIR SULFATEACTIVE INGREDIENTJ220T4J9Q2ABACAVIR SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
ABACAVIRACTIVE MOIETYWR2TIP26VSABACAVIR SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UABACAVIR SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ABACAVIR SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTABACAVIR SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOABACAVIR SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ABACAVIR SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AABACAVIR SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ABACAVIR SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ABACAVIR SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPABACAVIR SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
ABACAVIR SULFATEACTIVE INGREDIENTJ220T4J9Q2ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
ABACAVIRACTIVE MOIETYWR2TIP26VSABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPABACAVIR SULFATE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
ABACAVIR SULFATEACTIVE INGREDIENTJ220T4J9Q2ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ABACAVIRACTIVE MOIETYWR2TIP26VSABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPABACAVIR SULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-4105ABACAVIR SULFATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 2 package rows20250115_5676d391-f9a4-44be-9604-954b3d8d0e2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242679abacavir 300 MG Oral TabletPSN80c1702a-973c-436a-90f8-69b29674dca013
242679abacavir 300 MG Oral TabletSCD80c1702a-973c-436a-90f8-69b29674dca013
242679abacavir (as abacavir sulfate) 300 MG Oral TabletSY80c1702a-973c-436a-90f8-69b29674dca013
242679abacavir 300 MG Oral TabletPSN5676d391-f9a4-44be-9604-954b3d8d0e2b12
242679abacavir 300 MG Oral TabletSCD5676d391-f9a4-44be-9604-954b3d8d0e2b12
242679abacavir (as abacavir sulfate) 300 MG Oral TabletSY5676d391-f9a4-44be-9604-954b3d8d0e2b12
242679abacavir 300 MG Oral TabletPSNf7633480-25aa-4326-bec9-82835b486a202
242679abacavir 300 MG Oral TabletSCDf7633480-25aa-4326-bec9-82835b486a202
242679abacavir (as abacavir sulfate) 300 MG Oral TabletSYf7633480-25aa-4326-bec9-82835b486a202
242679abacavir 300 MG Oral TabletPSNe3961e38-20d5-4014-a9d5-1ab13611abb91
242679abacavir 300 MG Oral TabletSCDe3961e38-20d5-4014-a9d5-1ab13611abb91
242679abacavir (as abacavir sulfate) 300 MG Oral TabletSYe3961e38-20d5-4014-a9d5-1ab13611abb91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-4105-91003784105911 BOTTLE, PLASTIC in 1 CARTON (0378-4105-91) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2012-06-190000-00-00NoNoCurrent