Home NDC 50742-317 Flunisolide
Product NDC 50742-317
11-digit product format 507420317
Labeler code 50742
Product ID 50742-317_139fb92c-bb10-4ee9-8572-679ac540aa27
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Flunisolide
Dosage form SOLUTION
Route NASAL
Labeler Ingenus Pharmaceuticals, LLC
Application ANDA207802
Marketing category ANDA
Marketing start 2022-06-23
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 A207802-001 FLUNISOLIDE FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207802-001 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.
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 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207802-001 FLUNISOLIDE 0.025MG/SPRAY SPRAY, METERED / NASAL AB 2022-06-16 a50c72e98297…
Observed Orange Book normalized TE history# 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 50742-317-25 Flunisolide 25 mL in 1 BOTTLE, PUMP SOLUTION 25 2 50742-317-25 Flunisolide 1 in 1 CARTON SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50742-317 FLUNISOLIDE SOLUTION [INGENUS PHARMACEUTICALS, LLC] 2 Current NDC, Legacy NDC, 2 package rows 20250503_f39cae46-c68f-47ef-82f3-4fd3dd46c74c.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 50742-317-25 50742031725 1 BOTTLE, PUMP in 1 CARTON (50742-317-25) / 25 mL in 1 BOTTLE, PUMP 2022-06-23 0000-00-00 No No Current