Acyclovir
PRESCRIBING INFORMATION Acyclovir Capsules USP
Approved
Approval ID
37499620-6a17-40f1-b0db-dd79320ea21d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 6, 2017
Manufacturers
FDA
Carlsbad Technology, Inc.
DUNS: 781047246
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 Code61442-114
Application NumberANDA206261
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acyclovir
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 6, 2017
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ACYCLOVIRActive
Quantity: 200 mg in 1 1
Code: X4HES1O11F
Classification: ACTIB