Home NDC 0574-0611 PODOFILOX
Product NDC 0574-0611
11-digit product format 005740611
Labeler code 0574
Product ID 0574-0611_e75d3f9f-dd11-4c3e-9e6e-3d9af2cd76da
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PODOFILOX
Dosage form SOLUTION
Route TOPICAL
Labeler Padagis US LLC
Application ANDA075600
Marketing category ANDA
Marketing start 2002-01-29
Substance PODOFILOX
Active strength 5 mg/mL
Pharmacologic classes Decreased Mitosis [PE]
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 1 .
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 A075600-001 PODOFILOX PODOFILOX 0.5% SOLUTION / TOPICAL RS 2002-01-29
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.
Product history page 1 of 2 · 41 observed 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 2026-02-19 14:30 UTC 2026-02 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075600-001 PODOFILOX 0.5% SOLUTION / TOPICAL AT 2002-01-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base PODOFILOX
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PODOFILOX 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L36H50F353 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 582926 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 0574-0611-05 PODOFILOX 1 in 1 CARTON SOLUTION 1 9 0574-0611-05 PODOFILOX 3.5 mL in 1 BOTTLE, GLASS SOLUTION 3.5 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0574-0611 PODOFILOX SOLUTION [PADAGIS US LLC] 9 Current NDC, Legacy NDC, 2 package rows 20240312_6af07697-5203-43e0-ba35-83683af851c3.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 Marketing start Marketing end Sample Exclude flag Status 0574-0611-05 00574061105 1 BOTTLE, GLASS in 1 CARTON (0574-0611-05) / 3.5 mL in 1 BOTTLE, GLASS 2002-01-29 0000-00-00 No No Current