Home NDC 16714-502-02 Fluocinonide
Product NDC 16714-502
Requested package NDC 16714-502-02
11-digit product format 167140502
Labeler code 16714
Product ID 16714-502_397ece59-0740-4980-8953-0003b8b35c70
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluocinonide
Dosage form OINTMENT
Route TOPICAL
Labeler NORTHSTAR RX LLC
Application ANDA075008
Marketing category ANDA
Marketing start 1999-06-30
Marketing end 0000-00-00
Substance FLUOCINONIDE
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# 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A075008-001 FLUOCINONIDE FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075008-001 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.
Product history page 1 of 2 · 42 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 2026-08-18 06:07:40 2026-07 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075008-001 FLUOCINONIDE 0.05% OINTMENT / TOPICAL AB RS 1999-06-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16714-502-02 16714050202 1 TUBE in 1 CARTON (16714-502-02) > 30 g in 1 TUBE 1 tube 2016-08-15 0000-00-00 No No Current