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

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
69238-1791-7Penciclovir5 g in 1 TUBECREAM53
69238-1791-7Penciclovir1 in 1 CARTONCREAM13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1791-7GM - Gram69238-179142b8d532-10ce-4670-a4e4-5337b2434e7c12026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312255penciclovir 1 % Topical CreamPSN9118bbe9-8231-40c8-b11a-6c4a5f41aa163
312255penciclovir 10 MG/ML Topical CreamSCD9118bbe9-8231-40c8-b11a-6c4a5f41aa163
312255penciclovir 1 % Topical CreamSY9118bbe9-8231-40c8-b11a-6c4a5f41aa163

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69238-1791-7692381791071 TUBE in 1 CARTON (69238-1791-7) / 5 g in 1 TUBE1 tube2025-08-25NoNoCurrent