Penciclovir

Product NDC
0093-3186
11-digit product format
000933186
Labeler code
0093
Product ID
0093-3186_e6116cf2-000d-461f-a8cb-47f4c4ec8d34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penciclovir
Dosage form
CREAM
Route
TOPICAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA212710
Marketing category
ANDA
Marketing start
2022-11-14
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

Additional Listing Data#

Finished product
Yes
Brand name base
Penciclovir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PENCICLOVIR10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii359HUE8FJC
Rxcui312255

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1005b6ff-d0c1-48ab-8c99-f6ab62104661Product name220250401
39b4c6c3-4107-094f-96fa-0d1c48033493Product name220150326

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-3186-20Penciclovir1 in 1 CARTONCREAM11
0093-3186-20Penciclovir5 g in 1 TUBECREAM51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-3186-20GM - Gram0093-318613891649-3c2c-4792-8d8d-ed0d4fe731da12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-3186PENCICLOVIR CREAM [TEVA PHARMACEUTICALS USA, INC.]1Current NDC, Legacy NDC, 2 package rows20221116_5d95b934-2ba6-41b9-928f-6d2ce12f93f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312255penciclovir 1 % Topical CreamPSN5d95b934-2ba6-41b9-928f-6d2ce12f93f51
312255penciclovir 10 MG/ML Topical CreamSCD5d95b934-2ba6-41b9-928f-6d2ce12f93f51
312255penciclovir 1 % Topical CreamSY5d95b934-2ba6-41b9-928f-6d2ce12f93f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-3186-20000933186201 TUBE in 1 CARTON (0093-3186-20) / 5 g in 1 TUBE1 tube2022-11-140000-00-00NoNoCurrent