Acyclovir
Approved
Approval ID
dcc29902-1fe6-4713-947e-335503959464
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 9, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5687
Application NumberANDA077026
Product Classification
M
Marketing Category
C73584
G
Generic Name
acyclovir
Product Specifications
Route of AdministrationORAL
Effective DateJuly 9, 2010
FDA Product Classification
INGREDIENTS (8)
ACYCLOVIRActive
Quantity: 200 mg in 5 mL
Code: X4HES1O11F
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT