FDA.reportPublic FDA data

FLOVENT

Product NDC
50090-1245
11-digit product format
500901245
Labeler code
50090
Product ID
50090-1245_fb05bfe4-e8d9-4abb-afe1-d651eaa4eefd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone propionate
Dosage form
POWDER, METERED
Route
RESPIRATORY (INHALATION)
Labeler
A-S Medication Solutions
Application
NDA020833
Marketing category
NDA
Marketing start
2007-05-08
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
FLOVENT
Brand name suffix
DISKUS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE PROPIONATE50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO2GMZ0LF5W
Rxcui896018, 896019

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
50090-1245-02023-02-07C16284748780-1f386c64a-0a19-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FLOVENT DISKUS safely and effectively. See full prescribing information for FLOVENT DISKUS. FLOVENT DISKUS (fluticasone propionate inhalation powder), for oral inhalation use Initial U.S. Approval: 1994
50090-1245-02023-01-30C16284748780-1f386c64a-0a19-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FLOVENT DISKUS safely and effectively. See full prescribing information for FLOVENT DISKUS. FLOVENT DISKUS (fluticasone propionate inhalation powder), for oral inhalation use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1245-0FLOVENTDISKUS60 in 1 INHALERPOWDER, METERED6014
50090-1245-0FLOVENTDISKUS1 in 1 CARTONPOWDER, METERED114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1245-0EA - Each50090-124587f51c6c-193f-44dd-93ad-b37cb6ad9c5112018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1245FLOVENT DISKUS (FLUTICASONE PROPIONATE) POWDER, METERED [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 2 package rows20240112_038e6c40-9421-40ef-874b-8f4d7110a74a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896019Flovent Diskus 50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN038e6c40-9421-40ef-874b-8f4d7110a74a14
896018fluticasone propionate 50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN038e6c40-9421-40ef-874b-8f4d7110a74a14
89601960 ACTUAT fluticasone propionate 0.05 MG/ACTUAT Dry Powder Inhaler [Flovent]SBD038e6c40-9421-40ef-874b-8f4d7110a74a14
89601860 ACTUAT fluticasone propionate 0.05 MG/ACTUAT Dry Powder InhalerSCD038e6c40-9421-40ef-874b-8f4d7110a74a14
89601960 ACTUAT Flovent 0.05 MG/ACTUAT Dry Powder InhalerSY038e6c40-9421-40ef-874b-8f4d7110a74a14
896019Flovent Diskus 0.05 MG/ACTUAT Dry Powder Inhaler, 60 ACTUATSY038e6c40-9421-40ef-874b-8f4d7110a74a14
896019Flovent Diskus 50 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUATSY038e6c40-9421-40ef-874b-8f4d7110a74a14
896018fluticasone propionate 0.05 MG/ACTUAT Dry Powder Inhaler, 60 ACTUATSY038e6c40-9421-40ef-874b-8f4d7110a74a14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1245-0500901245001 INHALER in 1 CARTON (50090-1245-0) / 60 POWDER, METERED in 1 INHALER1 inhaler2014-11-280000-00-00NoNoCurrent