acyclovir
Acyclovir Tablets, USP Rx only
Approved
Approval ID
8d9fea43-6c04-40d7-8aac-398c2de2a558
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 24, 2023
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
acyclovir
PRODUCT DETAILS
NDC Product Code65841-803
Application NumberANDA204314
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 24, 2023
Generic Nameacyclovir
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ACYCLOVIRActive
Quantity: 800 mg in 1 1
Code: X4HES1O11F
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
acyclovir
PRODUCT DETAILS
NDC Product Code65841-802
Application NumberANDA204314
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 24, 2023
Generic Nameacyclovir
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ACYCLOVIRActive
Quantity: 400 mg in 1 1
Code: X4HES1O11F
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT