FDA.reportPublic FDA data

Fluticasone Propionate

Product NDC
50090-0968
11-digit product format
500900968
Labeler code
50090
Product ID
50090-0968_c55b417f-4588-43a6-b925-dcba58c555c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
A-S Medication Solutions
Application
ANDA077538
Marketing category
ANDA
Marketing start
2007-09-19
Substance
FLUTICASONE PROPIONATE
Active strength
50 ug/1
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
Fluticasone Propionate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE PROPIONATE50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO2GMZ0LF5W
Rxcui1797907

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33Product name320260126
343e8617-eb68-1e10-cfa9-8c30af285764Product name320240513
a31ad3df-8021-2ea1-94eb-0fe2f49b7729Product name420220719
813fe018-3e3c-40e4-8f71-7ab50f3dfe81Product name220180723
3bcd721e-0555-4bc3-96c6-690471ff9d94Product name120171113
9f9452df-fa34-43d4-97fe-c6605344c5a8Product name120171113
0e5a25a6-9f05-44b5-8449-aa63e59f7202Product name120170426
f3c5232f-03de-44f5-996a-90cd9c08bc60Product name120170426
1cb17fbb-0da4-2841-37bc-e7079783e1a2Product name120140508
667f427a-8698-a508-767a-53ed61b4c2e9Product name120140508
6a97ffc8-1d4d-a971-4978-85ba3a22eac9Product name120140508
6df84e13-2223-fa46-1e26-17e2f58a1e1cProduct name120140508
90fec588-984c-4375-cfd4-7e40114bdf80Product name120140508
9c1d3c48-b162-204b-f55b-e0f25c31c52eProduct name120140508
9fdb6139-394b-1510-4baf-bde68c419789Product name120140508
aef26912-037b-9a4e-db49-225ef6dfd8f1Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0968-02023-04-17C16284748780-1f386c649-ace6-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FLUTICASONE PROPIONATE nasal spray safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE nasal spray . FLUTICASONE PROPIONATE nasal spray, USP Initial U.S. Approval: 1994
50090-0968-02023-01-30C16284748780-1f386c649-ace6-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FLUTICASONE PROPIONATE nasal spray safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE nasal spray . FLUTICASONE PROPIONATE nasal spray, USP Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0968-0Fluticasone Propionate1 in 1 CARTONSPRAY, METERED111
50090-0968-0Fluticasone Propionate120 in 1 BOTTLE, SPRAYSPRAY, METERED12011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0968-0GM - Gram50090-0968bacd70dd-ca96-458a-a6ea-ad9fbff2424112021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0968FLUTICASONE PROPIONATE SPRAY, METERED [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 2 package rows20230418_e2df3810-3b92-4678-8f62-683c656b1de9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNe2df3810-3b92-4678-8f62-683c656b1de911
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDe2df3810-3b92-4678-8f62-683c656b1de911
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySYe2df3810-3b92-4678-8f62-683c656b1de911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0968-0500900968001 BOTTLE, SPRAY in 1 CARTON (50090-0968-0) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY2014-11-280000-00-00NoNoCurrent