ACYCLOVIR
Approved
Approval ID
3b80d222-4d88-4ddd-afbf-8f316e9463d5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 10, 2011
Manufacturers
FDA
Stat Rx USA
DUNS: 786036330
Products 2
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 Code16590-003
Application NumberANDA074980
Product Classification
M
Marketing Category
C73584
G
Generic Name
ACYCLOVIR
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2009
FDA Product Classification
INGREDIENTS (3)
ACYCLOVIRActive
Quantity: 800 mg in 1 1
Code: X4HES1O11F
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ACYCLOVIR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-370
Application NumberANDA074980
Product Classification
M
Marketing Category
C73584
G
Generic Name
ACYCLOVIR
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2009
FDA Product Classification
INGREDIENTS (4)
ACYCLOVIRActive
Quantity: 400 mg in 1 1
Code: X4HES1O11F
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT