Home NDC 64980-329 Fluocinolone Acetonide
Product NDC 64980-329
11-digit product format 649800329
Labeler code 64980
Product ID 64980-329_4e01be19-15cd-4b8f-bbae-158c27b556f3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluocinolone Acetonide
Dosage form OIL
Route AURICULAR (OTIC)
Labeler Rising Pharma Holdings, Inc.
Application ANDA203378
Marketing category ANDA
Marketing start 2016-09-14
Substance FLUOCINOLONE ACETONIDE
Active strength .11 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 A203378-001 FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203378-001 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 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203378-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2016-04-25 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
Brand name suffix Oil
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOCINOLONE ACETONIDE .11 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 1191299 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 64980-329-20 Fluocinolone AcetonideOil 20 mL in 1 BOTTLE OIL 20 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-329 FLUOCINOLONE ACETONIDE OIL OIL [RISING PHARMA HOLDINGS, INC.] 6 Current NDC, Legacy NDC, 1 package rows 20250418_79591576-1eab-48c5-b0a6-e205b3cc097e.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 Marketing end Sample Exclude flag Status 64980-329-20 64980032920 20 mL in 1 BOTTLE (64980-329-20) 20 ml 2016-09-14 0000-00-00 No No Current