Home NDC 68682-344 Flunisolide
Product NDC 68682-344
11-digit product format 686820344
Labeler code 68682
Product ID 68682-344_7e2cb3f0-5475-4c13-aadd-7cd14047a978
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Flunisolide
Dosage form SOLUTION
Route NASAL
Labeler Oceanside Pharmaceuticals
Application ANDA074805
Marketing category ANDA
Marketing start 2025-06-01
Substance FLUNISOLIDE
Active strength .25 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 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 A074805-001 FLUNISOLIDE FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074805-001 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 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074805-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-02-20 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Flunisolide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUNISOLIDE .25 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination QK4DYS664X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1797863 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 68682-344-25 Flunisolide 25 mL in 1 BOTTLE, PUMP SOLUTION 25 7 68682-344-25 Flunisolide 1 in 1 CARTON SOLUTION 1 7
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68682-344-25 68682034425 1 BOTTLE, PUMP in 1 CARTON (68682-344-25) / 25 mL in 1 BOTTLE, PUMP 2025-06-01 No No Current