Home NDC 52565-017-60 Flurandrenolide
Product NDC 52565-017
Requested package NDC 52565-017-60
11-digit product format 525650017
Labeler code 52565
Product ID 52565-017_25bacae9-c26d-40d7-8844-66d947ce58d6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Flurandrenolide
Dosage form OINTMENT
Route TOPICAL
Labeler Teligent Pharma, Inc.
Application ANDA207851
Marketing category ANDA
Marketing start 2016-12-30
Marketing end 0000-00-00
Substance FLURANDRENOLIDE
Active strength 1 mg/g
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
Historic NDC status page 1 of 1 · 9 matching rows.
Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 52565-017 52565-017-60 I Inactivated by FDA excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 52565-017 52565-017-60 I Inactivated by FDA excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 52565-017 52565-017-60 I Inactivated by FDA excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 52565-017 52565-017-60 I Inactivated by FDA excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 52565-017 52565-017-60 I Inactivated by FDA excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 52565-017 52565-017-60 I Inactivated by FDA excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 52565-017 52565-017-60 I Inactivated by FDA excluded / ndc_excluded.zip 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 52565-017 52565-017-60 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 52565-017 52565-017-60 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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 A207851-001 FLURANDRENOLIDE FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL RS 2016-12-30
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 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL RS 2016-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL RS 2016-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL RS 2016-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL RS 2016-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL RS 2016-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL RS 2016-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL RS 2016-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL RS 2016-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL RS 2016-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL RS 2016-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL RS 2016-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL RS 2016-12-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL RS 2016-12-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL RS 2016-12-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL AT 2016-12-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL AT 2016-12-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL AT 2016-12-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL AT 2016-12-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL AT 2016-12-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL AT 2016-12-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL AT 2016-12-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL AT 2016-12-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL AT 2016-12-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL AT 2016-12-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL AT 2016-12-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL AT 2016-12-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL AT 2016-12-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL RS 2016-12-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL RS 2016-12-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL RS 2016-12-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL RS 2016-12-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL RS 2016-12-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL RS 2016-12-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL RS 2016-12-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL AT 2016-12-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL AT 2016-12-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL AT 2016-12-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL AT 2016-12-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL AT 2016-12-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207851-001 FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL AT 2016-12-30 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52565-017-15 Flurandrenolide 1 in 1 CARTON OINTMENT 1 2 52565-017-15 Flurandrenolide 15 g in 1 TUBE OINTMENT 15 2 52565-017-30 Flurandrenolide 30 g in 1 TUBE OINTMENT 30 2 52565-017-30 Flurandrenolide 1 in 1 CARTON OINTMENT 1 2 52565-017-60 Flurandrenolide 1 in 1 CARTON OINTMENT 1 2 52565-017-60 Flurandrenolide 60 g in 1 TUBE OINTMENT 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52565-017 FLURANDRENOLIDE (FLURANDRENOLIDE) OINTMENT [TELIGENT PHARMA, INC.] 2 Legacy NDC, 6 package rows 20190911_14709d5d-186c-41f1-a7cc-e08872ad6e28.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52565-017-60 52565001760 1 TUBE in 1 CARTON (52565-017-60) > 60 g in 1 TUBE 1 tube 2016-12-30 0000-00-00 No No Current