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

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 Identifiers#

Field, Values table
FieldValues
UniiQK4DYS664X
Rxcui1797863

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
68682-344-25Flunisolide25 mL in 1 BOTTLE, PUMPSOLUTION257
68682-344-25Flunisolide1 in 1 CARTONSOLUTION17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797863flunisolide 25 MCG/ACTUAT Metered Dose Nasal SprayPSN50d87523-e1fb-4342-825f-9dba972c6a257
1797863flunisolide 0.025 MG/ACTUAT Metered Dose Nasal SpraySCD50d87523-e1fb-4342-825f-9dba972c6a257
1797863flunisolide 25 MCG/ACTUAT Metered Dose Nasal SpraySY50d87523-e1fb-4342-825f-9dba972c6a257

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68682-344-25686820344251 BOTTLE, PUMP in 1 CARTON (68682-344-25) / 25 mL in 1 BOTTLE, PUMP2025-06-01NoNoCurrent