FDA.reportPublic FDA data

Abacavir

Product NDC
50268-049
11-digit product format
502680049
Labeler code
50268
Product ID
50268-049_47e2137a-9afb-1285-e063-6294a90a4979
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abacavir
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA091560
Marketing category
ANDA
Marketing start
2020-04-10
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
50268-049-11Abacavir1 in 1 BLISTER PACKTABLET14
50268-049-12Abacavir20 in 1 BOXTABLET204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-049-11EA - Each50268-0490d522d20-eaed-4bbd-bf21-26859926e3cc12020-05-08
50268-049-12EA - Each50268-049da5c5a81-12c4-4f4e-95d6-512e5540274912020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-049ABACAVIR TABLET [AVPAK]3Current NDC, Legacy NDC, 2 package rows20220517_a2f06528-f3c5-2466-e053-2995a90ae18a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242679abacavir 300 MG Oral TabletPSNa2f06528-f3c5-2466-e053-2995a90ae18a4
242679abacavir 300 MG Oral TabletSCDa2f06528-f3c5-2466-e053-2995a90ae18a4
242679abacavir (as abacavir sulfate) 300 MG Oral TabletSYa2f06528-f3c5-2466-e053-2995a90ae18a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-049-11502680049111 in 1 BLISTER PACKHistorical
50268-049-125026800491220 BLISTER PACK in 1 BOX (50268-049-12) / 1 TABLET in 1 BLISTER PACK (50268-049-11) 20 blister pack2020-04-100000-00-00NoNoCurrent