Abacavir

Product NDC
0904-6874
11-digit product format
009046874
Labeler code
0904
Product ID
0904-6874_8a0bf056-72b0-4a2e-8eb8-988fbf101b5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abacavir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
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
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
0904-6874-04Abacavir30 in 1 CARTONTABLET, FILM COATED306
0904-6874-04Abacavir1 in 1 BLISTER PACKTABLET, FILM COATED16
0904-6874-06Abacavir50 in 1 CARTONTABLET, FILM COATED506
0904-6874-06Abacavir1 in 1 BLISTER PACKTABLET, FILM COATED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6874-04EA - Each0904-6874450f3c89-e206-465a-820c-3b2e22c0905d12019-11-12
0904-6874-06EA - Each0904-6874adb8f4f0-6ae0-4b77-ac80-ba512ea8bf6d12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6874ABACAVIR TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 4 package rows20250228_4b286ec6-68a7-4ec0-af07-5a27ec9cb35d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6874-040090468740430 BLISTER PACK in 1 CARTON (0904-6874-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK30 blister pack2012-12-170000-00-00NoNoCurrent
0904-6874-060090468740650 BLISTER PACK in 1 CARTON (0904-6874-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK50 blister pack2012-12-170000-00-00NoNoCurrent