ZIAGEN

Product NDC
53808-0811
11-digit product format
538080811
Labeler code
53808
Product ID
53808-0811_dd74d4f9-ed20-47b0-bb3d-4a8ad228a21e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
abacavir sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA020977
Marketing category
NDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
ABACAVIR SULFATE
Active strength
300 mg/1
Pharmacologic classes
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0811-1ZIAGEN1 in 1 BLISTER PACKTABLET, FILM COATED11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ABACAVIR SULFATEACTIVE INGREDIENTJ220T4J9Q2ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ABACAVIRACTIVE MOIETYWR2TIP26VSZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIACETININACTIVE INGREDIENTXHX3C3X673ZIAGEN (ABACAVIR 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
53808-0811ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100526_ff62bcaa-a200-4ebf-a9ca-1ab2c254751c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242679abacavir 300 MG Oral TabletPSNff62bcaa-a200-4ebf-a9ca-1ab2c254751c1
213460Ziagen 300 MG Oral TabletPSNff62bcaa-a200-4ebf-a9ca-1ab2c254751c1
213460abacavir 300 MG Oral Tablet [Ziagen]SBDff62bcaa-a200-4ebf-a9ca-1ab2c254751c1
242679abacavir 300 MG Oral TabletSCDff62bcaa-a200-4ebf-a9ca-1ab2c254751c1
242679abacavir (as abacavir sulfate) 300 MG Oral TabletSYff62bcaa-a200-4ebf-a9ca-1ab2c254751c1
213460Ziagen 300 MG Oral TabletSYff62bcaa-a200-4ebf-a9ca-1ab2c254751c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0811-1538080811011 in 1 BLISTER PACKHistorical