Acyclovir
Approved
Approval ID
6a9ea291-4ad5-48a8-8c08-5a17c8757549
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2023
Manufacturers
FDA
Advagen Pharma Limited
DUNS: 051627256
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 Code72888-079
Application NumberANDA215724
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acyclovir
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
INGREDIENTS (8)
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
BANANAInactive
Code: 4AJZ4765R9
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ACYCLOVIRActive
Quantity: 200 mg in 5 mL
Code: X4HES1O11F
Classification: ACTIB
SORBITOLInactive
Code: 506T60A25R
Classification: IACT