FDA.reportPublic FDA data

Fluticasone Propionate

Product NDC
45802-222
11-digit product format
458020222
Labeler code
45802
Product ID
45802-222_70491ace-9b54-4acc-8ceb-4c8383c9e9f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-222-11Fluticasone Propionate1 in 1 CARTONCREAM112
45802-222-11Fluticasone Propionate30 g in 1 TUBECREAM3012
45802-222-35Fluticasone Propionate15 g in 1 TUBECREAM1512
45802-222-35Fluticasone Propionate1 in 1 CARTONCREAM112
45802-222-37Fluticasone Propionate1 in 1 CARTONCREAM112
45802-222-37Fluticasone Propionate60 g in 1 TUBECREAM6012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-222-11GM - Gram45802-2226fb226f2-28f3-4d90-add0-bfa223e4aa9e12012-07-24
45802-222-35GM - Gram45802-2227725fc06-0d04-426a-b3b5-83b757feaa4c12012-07-24
45802-222-37GM - Gram45802-2226c37ec15-d605-4c27-a46e-f6f2ae2bd89812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Fluticasone PropionateACTIVE INGREDIENTO2GMZ0LF5WFLUTICASONE PROPIONATE CREAM [PERRIGO NEW YORK INC]6
FluticasoneACTIVE MOIETYCUT2W21N7UFLUTICASONE PROPIONATE CREAM [PERRIGO NEW YORK INC]6
CETETH-20INACTIVE INGREDIENTI835H2IHHXFLUTICASONE PROPIONATE CREAM [PERRIGO NEW YORK INC]6
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SFLUTICASONE PROPIONATE CREAM [PERRIGO NEW YORK INC]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPFLUTICASONE PROPIONATE CREAM [PERRIGO NEW YORK INC]6
IMIDUREAINACTIVE INGREDIENTM629807ATLFLUTICASONE PROPIONATE CREAM [PERRIGO NEW YORK INC]6
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSFLUTICASONE PROPIONATE CREAM [PERRIGO NEW YORK INC]6
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPFLUTICASONE PROPIONATE CREAM [PERRIGO NEW YORK INC]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUTICASONE PROPIONATE CREAM [PERRIGO NEW YORK INC]6
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74FLUTICASONE PROPIONATE CREAM [PERRIGO NEW YORK INC]6
WATERINACTIVE INGREDIENT059QF0KO0RFLUTICASONE PROPIONATE CREAM [PERRIGO NEW YORK INC]6
Fluticasone PropionateACTIVE INGREDIENTO2GMZ0LF5WFLUTICASONE PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]2
FluticasoneACTIVE MOIETYCUT2W21N7UFLUTICASONE PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]2
CETETH-20INACTIVE INGREDIENTI835H2IHHXFLUTICASONE PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SFLUTICASONE PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPFLUTICASONE PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]2
IMIDUREAINACTIVE INGREDIENTM629807ATLFLUTICASONE PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]2
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSFLUTICASONE PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPFLUTICASONE PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUTICASONE PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74FLUTICASONE PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RFLUTICASONE PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-222FLUTICASONE PROPIONATE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]12Current NDC, Legacy NDC, 6 package rows20240509_78e056e2-d39e-4d20-9ab2-332bd6973619.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895987fluticasone propionate 0.05 % Topical CreamPSN0cd0b88c-1ab3-4699-8eda-554054b8d33c104
895987fluticasone propionate 0.05 % Topical CreamPSN36c0e343-5bd4-447e-8651-c5f44d2ffd7c104
895987fluticasone propionate 0.5 MG/ML Topical CreamSCD0cd0b88c-1ab3-4699-8eda-554054b8d33c104
895987fluticasone propionate 0.5 MG/ML Topical CreamSCD36c0e343-5bd4-447e-8651-c5f44d2ffd7c104
895987fluticasone propionate 0.05 % Topical CreamSY0cd0b88c-1ab3-4699-8eda-554054b8d33c104
895987fluticasone propionate 0.05 % Topical CreamSY36c0e343-5bd4-447e-8651-c5f44d2ffd7c104
895987fluticasone propionate 0.05 % Topical CreamPSN0120296b-bebc-4a2d-8058-6caf41f96e52103
895987fluticasone propionate 0.05 % Topical CreamPSN8bd6f3a4-87f7-449e-8fcc-fec1537fcab3103
895987fluticasone propionate 0.5 MG/ML Topical CreamSCD0120296b-bebc-4a2d-8058-6caf41f96e52103
895987fluticasone propionate 0.5 MG/ML Topical CreamSCD8bd6f3a4-87f7-449e-8fcc-fec1537fcab3103
895987fluticasone propionate 0.05 % Topical CreamSY8bd6f3a4-87f7-449e-8fcc-fec1537fcab3103
895987fluticasone propionate 0.05 % Topical CreamSY0120296b-bebc-4a2d-8058-6caf41f96e52103
895987fluticasone propionate 0.05 % Topical CreamPSN4a4b7242-1083-4912-a318-25c3914aaf2212
895987fluticasone propionate 0.05 % Topical CreamPSN78e056e2-d39e-4d20-9ab2-332bd697361912
895987fluticasone propionate 0.5 MG/ML Topical CreamSCD4a4b7242-1083-4912-a318-25c3914aaf2212
895987fluticasone propionate 0.5 MG/ML Topical CreamSCD78e056e2-d39e-4d20-9ab2-332bd697361912
895987fluticasone propionate 0.05 % Topical CreamSY4a4b7242-1083-4912-a318-25c3914aaf2212
895987fluticasone propionate 0.05 % Topical CreamSY78e056e2-d39e-4d20-9ab2-332bd697361912
895987fluticasone propionate 0.05 % Topical CreamPSN10f6099a-c53c-4b0c-b81e-136c0e9f13d92
895987fluticasone propionate 0.5 MG/ML Topical CreamSCD10f6099a-c53c-4b0c-b81e-136c0e9f13d92
895987fluticasone propionate 0.05 % Topical CreamSY10f6099a-c53c-4b0c-b81e-136c0e9f13d92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-222-11458020222111 TUBE in 1 CARTON (45802-222-11) / 30 g in 1 TUBE1 tube2007-10-310000-00-00NoNoCurrent
45802-222-35458020222351 TUBE in 1 CARTON (45802-222-35) / 15 g in 1 TUBE1 tube2007-12-170000-00-00NoNoCurrent
45802-222-37458020222371 TUBE in 1 CARTON (45802-222-37) / 60 g in 1 TUBE1 tube2006-09-130000-00-00NoNoCurrent