FDA.reportPublic FDA data

Fluticasone Propionate

Product NDC
50090-1187
11-digit product format
500901187
Labeler code
50090
Product ID
50090-1187_1bf04358-8372-41a8-b4cc-2cce4a8edef4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA076793
Marketing category
ANDA
Marketing start
2006-09-13
Substance
FLUTICASONE PROPIONATE
Active strength
.5 mg/g
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 PROPIONATE.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO2GMZ0LF5W
Rxcui895987

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
50090-1187-02023-02-07C16284748780-1f386c649-b760-0266-e053-dadaa90a7c1aFluticasone Propionate Cream, 0.05%
50090-1187-02023-01-30C16284748780-1f386c649-b760-0266-e053-dadaa90a7c1aFluticasone Propionate Cream, 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1187-0Fluticasone Propionate1 in 1 CARTONCREAM112
50090-1187-0Fluticasone Propionate60 g in 1 TUBECREAM6012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1187-0GM - Gram50090-118708222ba5-0978-4b09-bb2d-25683367b1c412018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1187FLUTICASONE PROPIONATE CREAM [A-S MEDICATION SOLUTIONS]12Current NDC, Legacy NDC, 2 package rows20240112_4a4b7242-1083-4912-a318-25c3914aaf22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895987fluticasone propionate 0.05 % Topical CreamPSN4a4b7242-1083-4912-a318-25c3914aaf2212
895987fluticasone propionate 0.5 MG/ML Topical CreamSCD4a4b7242-1083-4912-a318-25c3914aaf2212
895987fluticasone propionate 0.05 % Topical CreamSY4a4b7242-1083-4912-a318-25c3914aaf2212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1187-0500901187001 TUBE in 1 CARTON (50090-1187-0) / 60 g in 1 TUBE1 tube2014-11-280000-00-00NoNoCurrent