Home NDC 63629-9584-1 Fluocinolone Acetonide Topical Solution USP, 0.01%
Product NDC 63629-9584
Requested package NDC 63629-9584-1
11-digit product format 636299584
Labeler code 63629
Product ID 63629-9584_266c3c51-3913-4823-812b-7704a2caa570
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluocinolone Acetonide Topical Solution USP, 0.01%
Dosage form SOLUTION
Route TOPICAL
Labeler Bryant Ranch Prepack
Application ANDA209913
Marketing category ANDA
Marketing start 2019-03-20
Substance FLUOCINOLONE ACETONIDE
Active strength .1 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 A209913-001 FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209913-001 AT
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 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209913-001 FLUOCINOLONE ACETONIDE 0.01% SOLUTION / TOPICAL AT 2019-02-13 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fluocinolone Acetonide Topical Solution USP, 0.01%
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOCINOLONE ACETONIDE .1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0CD5FD6S2M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1191310 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 63629-9584-1 Fluocinolone Acetonide Topical Solution USP, 0.01% 60 mL in 1 BOTTLE SOLUTION 60 104 63629-9584-1 Fluocinolone Acetonide Topical Solution USP, 0.01% 1 in 1 CARTON SOLUTION 1 104
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-9584 FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% SOLUTION [BRYANT RANCH PREPACK] 104 Current NDC, Legacy NDC, 2 package rows 20240821_ce89966d-d7ea-4986-936e-6d46aee497cd.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 · 3 matching rows.
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 63629-9584-1 63629958401 1 BOTTLE in 1 CARTON (63629-9584-1) / 60 mL in 1 BOTTLE 1 bottle 2022-12-12 0000-00-00 No No Current