Abacavir

Product NDC
65862-089
11-digit product format
658620089
Labeler code
65862
Product ID
65862-089_e1bbcda5-e1ce-48d6-99d0-8545112b08c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abacavir Sulfate
Dosage form
SOLUTION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA077950
Marketing category
ANDA
Marketing start
2018-03-14
Substance
ABACAVIR SULFATE
Active strength
20 mg/mL
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 SULFATE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ220T4J9Q2
Rxcui242680

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
65862-089-24Abacavir240 mL in 1 BOTTLESOLUTION2406
65862-089-24Abacavir1 in 1 CARTONSOLUTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-089ABACAVIR (ABACAVIR SULFATE) SOLUTION [AUROBINDO PHARMA LIMITED]6Current NDC, Legacy NDC, 2 package rows20240510_e2214976-657c-4018-b059-1ad66a7e2b6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242680abacavir 20 MG in 1 mL Oral SolutionPSNe2214976-657c-4018-b059-1ad66a7e2b6f6
242680abacavir 20 MG/ML Oral SolutionSCDe2214976-657c-4018-b059-1ad66a7e2b6f6
242680abacavir (as abacavir sulfate) 20 MG per 1 ML Oral SolutionSYe2214976-657c-4018-b059-1ad66a7e2b6f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-089-24658620089241 BOTTLE in 1 CARTON (65862-089-24) / 240 mL in 1 BOTTLE1 bottle2018-03-140000-00-00NoNoCurrent