Home NDC 39328-079-20 Flac Otic Oil
Product NDC 39328-079
Requested package NDC 39328-079-20
11-digit product format 393280079
Labeler code 39328
Product ID 39328-079_b9a91a1b-2c51-4ef3-8152-7a720061b5aa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluocinolone acetonide
Dosage form OIL
Route AURICULAR (OTIC)
Labeler Patrin Pharma, Inc.
Application ANDA210736
Marketing category ANDA
Marketing start 2018-04-12
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 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 39328-079 39328-079-20 I Inactivated by FDA excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 39328-079 39328-079-20 I Inactivated by FDA excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…
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 A210736-001 FLAC FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS / OTIC AT 2018-04-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210736-001 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 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210736-001 FLAC 0.01% OIL/DROPS / OTIC AT 2018-04-11 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 Flac Otic Oil
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1191299 Internal RxNorm lookup 2045201 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 39328-079-20 Flac Otic Oil 20 mL in 1 BOTTLE, DROPPER OIL 20 6 39328-079-20 Flac Otic Oil 1 in 1 CARTON OIL 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 39328-079 FLAC OTIC OIL (FLUOCINOLONE ACETONIDE) OIL [PATRIN PHARMA, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20241121_4b0a46b6-dcb7-4c4e-8b02-cf72eede3cbb.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 Marketing start Marketing end Sample Exclude flag Status 39328-079-20 39328007920 1 BOTTLE, DROPPER in 1 CARTON (39328-079-20) / 20 mL in 1 BOTTLE, DROPPER 2018-04-12 0000-00-00 No No Current