ZIAGEN
These highlights do not include all the information needed to use ZIAGEN safely and effectively. See full prescribing information for ZIAGEN. ZIAGEN (abacavir) tablets, for oral useZIAGEN (abacavir) oral solutionInitial U.S. Approval: 1998
Approved
Approval ID
ca73b519-015a-436d-aa3c-af53492825a1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 29, 2023
Manufacturers
FDA
ViiV Healthcare Company
DUNS: 027295585
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
abacavir sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49702-221
Application NumberNDA020977
Product Classification
M
Marketing Category
C73594
G
Generic Name
abacavir sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJune 3, 2019
FDA Product Classification
INGREDIENTS (10)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ABACAVIR SULFATEActive
Quantity: 300 mg in 1 1
Code: J220T4J9Q2
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
abacavir sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49702-222
Application NumberNDA020978
Product Classification
M
Marketing Category
C73594
G
Generic Name
abacavir sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJune 3, 2019
FDA Product Classification
INGREDIENTS (9)
ABACAVIR SULFATEActive
Quantity: 20 mg in 1 mL
Code: J220T4J9Q2
Classification: ACTIM
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT