Abacavir

Product NDC
67046-1602
11-digit product format
670461602
Labeler code
67046
Product ID
67046-1602_48c0d443-a111-0039-e063-6394a90a9076
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abacavir
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Abacavir
Listing expiration
2027-12-31

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
67046-1602-3Abacavir30 in 1 BLISTER PACKTABLET302

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
67046-1602-36704616020330 TABLET in 1 BLISTER PACK (67046-1602-3) 30 tablet2021-04-01NoNoHistorical