Acyclovir
Approved
Approval ID
c7317324-4654-4bcc-8edf-7b7cd8794d2e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 2, 2023
Manufacturers
FDA
Modavar Pharmaceuticals LLC
DUNS: 858949204
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acyclovir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72241-028
Application NumberANDA201445
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acyclovir
Product Specifications
Route of AdministrationORAL
Effective DateMarch 2, 2023
FDA Product Classification
INGREDIENTS (8)
ACYCLOVIRActive
Quantity: 200 mg in 1 1
Code: X4HES1O11F
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT