Home NDC 45802-440 PENCICLOVIR
Product NDC 45802-440
11-digit product format 458020440
Labeler code 45802
Product ID 45802-440_aa3c82bd-5e27-4b4d-af88-6b80e5779f2c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name penciclovir
Dosage form CREAM
Route TOPICAL
Labeler Padagis Israel Pharmaceuticals Ltd
Application ANDA212368
Marketing category ANDA
Marketing start 2024-11-07
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212368-001 PENCICLOVIR PENCICLOVIR 1% CREAM / TOPICAL AB 2024-09-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212368-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A212368-001 PENCICLOVIR 1% CREAM / TOPICAL AB 2024-09-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212368-001 PENCICLOVIR 1% CREAM / TOPICAL AB 2024-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212368-001 PENCICLOVIR 1% CREAM / TOPICAL AB 2024-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212368-001 PENCICLOVIR 1% CREAM / TOPICAL AB 2024-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212368-001 PENCICLOVIR 1% CREAM / TOPICAL AB 2024-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212368-001 PENCICLOVIR 1% CREAM / TOPICAL AB 2024-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212368-001 PENCICLOVIR 1% CREAM / TOPICAL AB 2024-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212368-001 PENCICLOVIR 1% CREAM / TOPICAL AB 2024-09-27 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212368-001 PENCICLOVIR 1% CREAM / TOPICAL AB 2024-09-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212368-001 PENCICLOVIR 1% CREAM / TOPICAL AB 2024-09-27 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212368-001 PENCICLOVIR 1% CREAM / TOPICAL AB 2024-09-27 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base PENCICLOVIR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PENCICLOVIR 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 359HUE8FJC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312255 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 45802-440-75 PENCICLOVIR 1 in 1 CARTON CREAM 1 2 45802-440-75 PENCICLOVIR 5 g in 1 TUBE CREAM 5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45802-440 PENCICLOVIR CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD] 2 Current NDC, 2 package rows 20241204_72da67d0-1349-4408-be13-9935bd9c0179.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 45802-440-75 45802044075 1 TUBE in 1 CARTON (45802-440-75) / 5 g in 1 TUBE 1 tube 2024-11-07 No No Current