Home NDC 0574-0621 Podofilox
Product NDC 0574-0621
11-digit product format 005740621
Labeler code 0574
Product ID 0574-0621_d2e70c5e-d4a9-4295-9eff-517ffb974e61
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Podofilox
Dosage form GEL
Route TOPICAL
Labeler Padagis US LLC
Application ANDA211871
Marketing category ANDA
Marketing start 2023-12-13
Substance PODOFILOX
Active strength 5 mg/g
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 A211871-001 PODOFILOX PODOFILOX 0.5% GEL / TOPICAL RS 2023-11-22
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 2026-02-19 14:30 UTC 2026-02 A211871-001 PODOFILOX 0.5% GEL / TOPICAL RS 2023-11-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211871-001 PODOFILOX 0.5% GEL / TOPICAL AB 2023-11-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211871-001 PODOFILOX 0.5% GEL / TOPICAL AB 2023-11-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211871-001 PODOFILOX 0.5% GEL / TOPICAL AB 2023-11-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211871-001 PODOFILOX 0.5% GEL / TOPICAL AB 2023-11-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211871-001 PODOFILOX 0.5% GEL / TOPICAL AB 2023-11-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211871-001 PODOFILOX 0.5% GEL / TOPICAL AB 2023-11-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211871-001 PODOFILOX 0.5% GEL / TOPICAL AB 2023-11-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211871-001 PODOFILOX 0.5% GEL / TOPICAL AB 2023-11-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211871-001 PODOFILOX 0.5% GEL / TOPICAL AB 2023-11-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211871-001 PODOFILOX 0.5% GEL / TOPICAL AB 2023-11-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211871-001 PODOFILOX 0.5% GEL / TOPICAL AB 2023-11-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211871-001 PODOFILOX 0.5% GEL / TOPICAL AB 2023-11-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211871-001 PODOFILOX 0.5% GEL / TOPICAL AB 2023-11-22 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211871-001 PODOFILOX 0.5% GEL / TOPICAL AB 2023-11-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211871-001 PODOFILOX 0.5% GEL / TOPICAL AB 2023-11-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211871-001 PODOFILOX 0.5% GEL / TOPICAL AB 2023-11-22 ea1830bbd6c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211871-001 PODOFILOX 0.5% GEL / TOPICAL RS 2023-11-22 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211871-001 CGT 2024-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211871-001 CGT 2024-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211871-001 CGT 2024-06-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211871-001 CGT 2024-06-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211871-001 CGT 2024-06-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211871-001 CGT 2024-06-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211871-001 CGT 2024-06-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211871-001 CGT 2024-06-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211871-001 CGT 2024-06-10 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211871-001 CGT 2024-06-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211871-001 CGT 2024-06-10 1c564ffb4f44…
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/g
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 312466 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 0574-0621-05 Podofilox 3.5 g in 1 TUBE, WITH APPLICATOR GEL 3.5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0574-0621 PODOFILOX GEL [PADAGIS US LLC] 2 Current NDC, 1 package rows 20231214_d2e70c5e-d4a9-4295-9eff-517ffb974e61.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 0574-0621-05 00574062105 3.5 g in 1 TUBE, WITH APPLICATOR (0574-0621-05) 3.5 g 2023-12-13 No No Current