Podofilox

Product NDC
63629-8832
11-digit product format
636298832
Labeler code
63629
Product ID
63629-8832_d44b372a-1809-439e-9a28-a04986e332d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Podofilox
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
NDA019795
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1990-12-13
Marketing end
0000-00-00
Substance
PODOFILOX
Active strength
5 mg/mL
Pharmacologic classes
Decreased Mitosis [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-8832DDiscontinued by firm2026-08-03
excluded packagepackage63629-883263629-8832-1DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-8832-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-8832-1f5e01cc5f278…a2eaf40c39c3…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019795-001CONDYLOXPODOFILOX0.5%SOLUTION / TOPICALRLD1990-12-13

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-1387673890dc5c…
2021-03-12 10:30 UTC2021-03N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-133f01610625f2…
2019-09-15 20:21 UTC2019-09N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-13b00525d2431f…
2019-07-19 19:46 UTC2019-07N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-133f0d92c62455…
2023-05-13 08:27 UTC2023-05N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-13053a50430f4f…
2023-01-26 05:58 UTC2023-01N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019795-001CONDYLOX0.5%SOLUTION / TOPICALATRLD, RS1990-12-13cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N019795-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019795-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019795-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019795-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019795-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019795-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019795-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019795-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019795-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019795-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019795-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019795-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019795-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019795-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019795-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019795-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019795-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019795-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019795-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019795-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019795-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03N019795-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019795-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019795-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019795-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N019795-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07N019795-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019795-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019795-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019795-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019795-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019795-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019795-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019795-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05N019795-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01N019795-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019795-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019795-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019795-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019795-001AT1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8832-1ML - Milliliter63629-88320c8b47db-668d-42d6-8c50-53ebcac7f20b12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8832PODOFILOX SOLUTION [BRYANT RANCH PREPACK]103Legacy NDC20230316_e4a1e4c4-46b5-4059-8075-951c2347a7a8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8832-1636298832013.5 mL in 1 BOTTLE, GLASS (63629-8832-1) 3.5 ml2021-12-270000-00-00NoNoCurrent