FDA.reportPublic FDA data

Fluticasone Propionate

Product NDC
45802-221
11-digit product format
458020221
Labeler code
45802
Product ID
45802-221_d4ab6f31-add7-41ec-912f-ae64bd61975e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA076668
Marketing category
ANDA
Marketing start
2007-07-09
Substance
FLUTICASONE PROPIONATE
Active strength
.05 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.05 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO2GMZ0LF5W
Rxcui895487

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-221-11Fluticasone Propionate1 in 1 CARTONOINTMENT114
45802-221-11Fluticasone Propionate30 g in 1 TUBEOINTMENT3014
45802-221-35Fluticasone Propionate1 in 1 CARTONOINTMENT114
45802-221-35Fluticasone Propionate15 g in 1 TUBEOINTMENT1514
45802-221-37Fluticasone Propionate60 g in 1 TUBEOINTMENT6014
45802-221-37Fluticasone Propionate1 in 1 CARTONOINTMENT114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-221-11GM - Gram45802-2213b8d582f-510c-46b0-b2e8-fe0a1f2a500712012-07-24
45802-221-35GM - Gram45802-2218e71491c-bccc-418b-ba22-da55c9b1997312012-07-24
45802-221-37GM - Gram45802-221992f7d60-ea39-4da9-b6c6-e7f6a2f369f912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5WFLUTICASONE PROPIONATE OINTMENT [PERRIGO NEW YORK INC]5
FLUTICASONEACTIVE MOIETYCUT2W21N7UFLUTICASONE PROPIONATE OINTMENT [PERRIGO NEW YORK INC]5
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KYFLUTICASONE PROPIONATE OINTMENT [PERRIGO NEW YORK INC]5
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPFLUTICASONE PROPIONATE OINTMENT [PERRIGO NEW YORK INC]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUTICASONE PROPIONATE OINTMENT [PERRIGO NEW YORK INC]5
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5AFLUTICASONE PROPIONATE OINTMENT [PERRIGO NEW YORK INC]5
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5WFLUTICASONE PROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
FLUTICASONEACTIVE MOIETYCUT2W21N7UFLUTICASONE PROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPFLUTICASONE PROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUTICASONE PROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5AFLUTICASONE PROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-221FLUTICASONE PROPIONATE OINTMENT [PADAGIS ISRAEL PHARMACEUTICALS LTD]14Current NDC, Legacy NDC, 6 package rows20240130_16985600-3f81-4d51-8bf7-0cbbd89856a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895487fluticasone propionate 0.005 % Topical OintmentPSN96e0681d-3788-49cc-8c0e-3185675b8da1104
895487fluticasone propionate 0.005 % Topical OintmentPSNf6aca9a9-0310-4c11-84b2-eacd19c45a1d104
895487fluticasone propionate 0.005 % Topical OintmentPSNaed4ac53-cf6e-489e-bb7e-b8c444e4339e104
895487fluticasone propionate 0.00005 MG/MG Topical OintmentSCD96e0681d-3788-49cc-8c0e-3185675b8da1104
895487fluticasone propionate 0.00005 MG/MG Topical OintmentSCDaed4ac53-cf6e-489e-bb7e-b8c444e4339e104
895487fluticasone propionate 0.00005 MG/MG Topical OintmentSCDf6aca9a9-0310-4c11-84b2-eacd19c45a1d104
895487fluticasone propionate 0.005 % Topical OintmentSY96e0681d-3788-49cc-8c0e-3185675b8da1104
895487fluticasone propionate 0.005 % Topical OintmentSYaed4ac53-cf6e-489e-bb7e-b8c444e4339e104
895487fluticasone propionate 0.005 % Topical OintmentSYf6aca9a9-0310-4c11-84b2-eacd19c45a1d104
895487fluticasone propionate 0.005 % Topical OintmentPSN8204a0c2-bd24-409a-b848-b3b369df642f100
895487fluticasone propionate 0.00005 MG/MG Topical OintmentSCD8204a0c2-bd24-409a-b848-b3b369df642f100
895487fluticasone propionate 0.005 % Topical OintmentSY8204a0c2-bd24-409a-b848-b3b369df642f100
895487fluticasone propionate 0.005 % Topical OintmentPSN16985600-3f81-4d51-8bf7-0cbbd89856a114
895487fluticasone propionate 0.00005 MG/MG Topical OintmentSCD16985600-3f81-4d51-8bf7-0cbbd89856a114
895487fluticasone propionate 0.005 % Topical OintmentSY16985600-3f81-4d51-8bf7-0cbbd89856a114
895487fluticasone propionate 0.005 % Topical OintmentPSN255e71b4-9e24-4ad2-93f6-0a0ade71d8232
895487fluticasone propionate 0.00005 MG/MG Topical OintmentSCD255e71b4-9e24-4ad2-93f6-0a0ade71d8232
895487fluticasone propionate 0.005 % Topical OintmentSY255e71b4-9e24-4ad2-93f6-0a0ade71d8232

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-221-11458020221111 TUBE in 1 CARTON (45802-221-11) / 30 g in 1 TUBE1 tube2007-07-090000-00-00NoNoCurrent
45802-221-35458020221351 TUBE in 1 CARTON (45802-221-35) / 15 g in 1 TUBE1 tube2008-02-120000-00-00NoNoCurrent
45802-221-37458020221371 TUBE in 1 CARTON (45802-221-37) / 60 g in 1 TUBE1 tube2007-10-310000-00-00NoNoCurrent