Penciclovir
These highlights do not include all the information needed to use PENCICLOVIR CREAM safely and effectively. See full prescribing information for PENCICLOVIR CREAM. PENCICLOVIR cream 1%, for topical use only Initial U.S. Approval: 1996
Approved
Approval ID
5d95b934-2ba6-41b9-928f-6d2ce12f93f5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 31, 2019
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Penciclovir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-3186
Application NumberANDA212710
Product Classification
M
Marketing Category
C73584
G
Generic Name
Penciclovir
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 31, 2019
FDA Product Classification
INGREDIENTS (7)
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
PENCICLOVIRActive
Quantity: 10 mg in 1 g
Code: 359HUE8FJC
Classification: ACTIB
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
WHITE PETROLATUMInactive
Code: B6E5W8RQJ4
Classification: IACT