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
NDC Product Code0093-3186
Application NumberANDA212710
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateMarch 31, 2019
Generic NamePenciclovir
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