Penciclovir

Product NDC
69238-1791
11-digit product format
692381791
Labeler code
69238
Product ID
69238-1791_1ca2d723-c10a-4170-a3e6-7a7f399c72f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penciclovir
Dosage form
CREAM
Route
TOPICAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA214100
Marketing category
ANDA
Marketing start
2025-08-25
Substance
PENCICLOVIR
Active strength
10 mg/g
Pharmacologic classes
DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
359HUE8FJCPENCICLOVIR39809-25-1PENCICLOVIR

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69238-1791-7692381791071 TUBE in 1 CARTON (69238-1791-7) / 5 g in 1 TUBE1 tube2025-08-25NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
PenciclovirAmneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals, LLC2020-07-31HUMAN PRESCRIPTION DRUG LABEL3