Home NDC 71335-2879-1 FLUOCINOLONE ACETONIDE
Product NDC 71335-2879
Requested package NDC 71335-2879-1
11-digit product format 713352879
Labeler code 71335
Product ID 71335-2879_0cd1128a-9159-4955-849b-054c9444ad0a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluocinolone acetonide
Dosage form OIL
Route AURICULAR (OTIC)
Labeler Bryant Ranch Prepack
Application ANDA212762
Marketing category ANDA
Marketing start 2021-04-02
Substance FLUOCINOLONE ACETONIDE
Active strength .11 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 A212762-001 FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212762-001 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.
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 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212762-001 FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2021-04-02 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base FLUOCINOLONE ACETONIDE
Listing expiration 2026-12-31 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 71335-2879-1 FLUOCINOLONE ACETONIDE 1 in 1 CARTON OIL 1 100 71335-2879-1 FLUOCINOLONE ACETONIDE 20 mL in 1 BOTTLE OIL 20 100
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 Sample Exclude flag Status 71335-2879-1 71335287901 1 BOTTLE in 1 CARTON (71335-2879-1) / 20 mL in 1 BOTTLE 1 bottle 2025-11-11 No No Current