ZIAGEN

Product NDC
49702-221
11-digit product format
497020221
Labeler code
49702
Product ID
49702-221_e1656a96-f3e0-450f-988c-52cc2f429cba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
abacavir sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ViiV Healthcare Company
Application
NDA020977
Marketing category
NDA
Marketing start
1998-12-29
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49702-221-18EA - Each49702-221eb8a1321-bf1b-4e34-9e70-4215597755cb12012-07-24
49702-221-44EA - Each49702-2219ac7422e-d48f-4550-bc93-676299ccbab112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ABACAVIR SULFATEACTIVE INGREDIENTJ220T4J9Q2ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY]17
ABACAVIRACTIVE MOIETYWR2TIP26VSZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY]17
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY]17
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY]17
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY]17
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY]17
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY]17
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY]17
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY]17
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY]17
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY]17
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY]17
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY]17
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY]17
SORBITOLINACTIVE INGREDIENT506T60A25RZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY]17
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY]17
TRIACETININACTIVE INGREDIENTXHX3C3X673ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY]17
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY]17
WATERINACTIVE INGREDIENT059QF0KO0RZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY]17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49702-221ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY]31Legacy NDC20240608_ca73b519-015a-436d-aa3c-af53492825a1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49702-221-184970202211860 TABLET, FILM COATED in 1 BOTTLE (49702-221-18) 1998-12-290000-00-00NoNoCurrent