Flunisolide

Product NDC
24208-344
11-digit product format
242080344
Labeler code
24208
Product ID
24208-344_103e2cf8-62f9-4911-995b-444bde83bcf6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flunisolide
Dosage form
SOLUTION
Route
NASAL
Labeler
Bausch & Lomb Incorporated
Application
ANDA074805
Marketing category
ANDA
Marketing start
2002-02-20
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074805-001FLUNISOLIDEFLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A074805-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-203f01610625f2…
2019-09-15 20:21 UTC2019-09A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074805-001FLUNISOLIDE0.025MG/SPRAYSPRAY, METERED / NASALABRS2002-02-20e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A074805-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074805-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074805-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074805-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074805-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074805-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074805-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074805-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074805-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074805-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074805-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074805-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074805-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074805-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074805-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074805-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074805-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074805-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074805-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074805-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074805-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074805-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A074805-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074805-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074805-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074805-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074805-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074805-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074805-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074805-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074805-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074805-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074805-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074805-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074805-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074805-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074805-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074805-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074805-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074805-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Flunisolide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUNISOLIDE.25 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QK4DYS664XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1797863Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7c72c954-3758-40c3-9977-d03b25d71e0aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0324fdff-f178-4b24-b132-71f36585443aProduct name120230313
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
bb5a3485-6770-5aae-e31b-36a749e6079eProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-344-25Flunisolide25 mL in 1 BOTTLE, PUMPSOLUTION2519
24208-344-25Flunisolide1 in 1 CARTONSOLUTION119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-344-25ML - Milliliter24208-34455267dab-3689-4461-8a44-a27508e560a712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUNISOLIDEACTIVE INGREDIENTQK4DYS664XFLUNISOLIDE SOLUTION [BAUSCH & LOMB INCORPORATED]5
FLUNISOLIDE ANHYDROUSACTIVE MOIETY78M02AA8KFFLUNISOLIDE SOLUTION [BAUSCH & LOMB INCORPORATED]5
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7FLUNISOLIDE SOLUTION [BAUSCH & LOMB INCORPORATED]5
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UFLUNISOLIDE SOLUTION [BAUSCH & LOMB INCORPORATED]5
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPFLUNISOLIDE SOLUTION [BAUSCH & LOMB INCORPORATED]5
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KFLUNISOLIDE SOLUTION [BAUSCH & LOMB INCORPORATED]5
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBFLUNISOLIDE SOLUTION [BAUSCH & LOMB INCORPORATED]5
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PFLUNISOLIDE SOLUTION [BAUSCH & LOMB INCORPORATED]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUNISOLIDE SOLUTION [BAUSCH & LOMB INCORPORATED]5
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRFLUNISOLIDE SOLUTION [BAUSCH & LOMB INCORPORATED]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFLUNISOLIDE SOLUTION [BAUSCH & LOMB INCORPORATED]5
WATERINACTIVE INGREDIENT059QF0KO0RFLUNISOLIDE SOLUTION [BAUSCH & LOMB INCORPORATED]5
FLUNISOLIDEACTIVE INGREDIENTQK4DYS664XFLUNISOLIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
FLUNISOLIDE ANHYDROUSACTIVE MOIETY78M02AA8KFFLUNISOLIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7FLUNISOLIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UFLUNISOLIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPFLUNISOLIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KFLUNISOLIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBFLUNISOLIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PFLUNISOLIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUNISOLIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRFLUNISOLIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFLUNISOLIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RFLUNISOLIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-344FLUNISOLIDE SOLUTION [BAUSCH & LOMB INCORPORATED]18Current NDC, Legacy NDC, 2 package rows20250119_7c72c954-3758-40c3-9977-d03b25d71e0a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FlunisolideFLUNISOLIDEOceanside Pharmaceuticals50d87523-e1fb-4342-825f-9dba972c6a252025-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074805
application number: ANDA074805
FlunisolideFLUNISOLIDEBausch & Lomb Incorporated7c72c954-3758-40c3-9977-d03b25d71e0a2025-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074805
application number: ANDA074805
ndc (product): 24208-344

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797863flunisolide 25 MCG/ACTUAT Metered Dose Nasal SprayPSN7c72c954-3758-40c3-9977-d03b25d71e0a19
1797863flunisolide 0.025 MG/ACTUAT Metered Dose Nasal SpraySCD7c72c954-3758-40c3-9977-d03b25d71e0a19
1797863flunisolide 25 MCG/ACTUAT Metered Dose Nasal SpraySY7c72c954-3758-40c3-9977-d03b25d71e0a19
1797863flunisolide 25 MCG/ACTUAT Metered Dose Nasal SprayPSNe2cad5b9-0a9b-4b62-8146-c602047983701
1797863flunisolide 0.025 MG/ACTUAT Metered Dose Nasal SpraySCDe2cad5b9-0a9b-4b62-8146-c602047983701
1797863flunisolide 25 MCG/ACTUAT Metered Dose Nasal SpraySYe2cad5b9-0a9b-4b62-8146-c602047983701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-344-25242080344251 BOTTLE, PUMP in 1 CARTON (24208-344-25) / 25 mL in 1 BOTTLE, PUMP2002-02-200000-00-00NoNoCurrent