FDA.reportPublic FDA data

FLUTICASONE PROPIONATE

Product NDC
58602-017
11-digit product format
586020017
Labeler code
58602
Product ID
58602-017_ef12e102-d407-457c-8f7b-ba7b91a6b733
Type
HUMAN OTC DRUG
Nonproprietary name
fluticasone propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Aurohealth LLC
Application
ANDA217088
Marketing category
ANDA
Marketing start
2024-05-10
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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
a31ad3df-8021-2ea1-94eb-0fe2f49b7729Product name420220719
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
813fe018-3e3c-40e4-8f71-7ab50f3dfe81Product name220180723
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
3bcd721e-0555-4bc3-96c6-690471ff9d94Product name120171113
9f9452df-fa34-43d4-97fe-c6605344c5a8Product name120171113
0e5a25a6-9f05-44b5-8449-aa63e59f7202Product name120170426
f3c5232f-03de-44f5-996a-90cd9c08bc60Product name120170426
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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
58602-017-42FLUTICASONE PROPIONATE60 in 1 BOTTLESPRAY, METERED604
58602-017-42FLUTICASONE PROPIONATE1 in 1 CARTONSPRAY, METERED14
58602-017-43FLUTICASONE PROPIONATE120 in 1 BOTTLESPRAY, METERED1204
58602-017-43FLUTICASONE PROPIONATE1 in 1 CARTONSPRAY, METERED14
58602-017-45FLUTICASONE PROPIONATE72 in 1 BOTTLESPRAY, METERED724
58602-017-45FLUTICASONE PROPIONATE1 in 1 CARTONSPRAY, METERED14
58602-017-46FLUTICASONE PROPIONATE72 in 1 BOTTLESPRAY, METERED724
58602-017-46FLUTICASONE PROPIONATE2 in 1 CARTONSPRAY, METERED24
58602-017-47FLUTICASONE PROPIONATE72 in 1 BOTTLESPRAY, METERED724
58602-017-47FLUTICASONE PROPIONATE3 in 1 CARTONSPRAY, METERED34
58602-017-48FLUTICASONE PROPIONATE144 in 1 BOTTLESPRAY, METERED1444
58602-017-48FLUTICASONE PROPIONATE1 in 1 CARTONSPRAY, METERED14
58602-017-49FLUTICASONE PROPIONATE2 in 1 CARTONSPRAY, METERED24
58602-017-49FLUTICASONE PROPIONATE144 in 1 BOTTLESPRAY, METERED1444
58602-017-50FLUTICASONE PROPIONATE144 in 1 BOTTLESPRAY, METERED1444
58602-017-50FLUTICASONE PROPIONATE3 in 1 CARTONSPRAY, METERED34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-017FLUTICASONE PROPIONATE SPRAY, METERED [AUROHEALTH LLC]3Current NDC, 16 package rows20250528_044a06a1-74fc-43ff-b136-37ad41220941.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN044a06a1-74fc-43ff-b136-37ad412209414
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD044a06a1-74fc-43ff-b136-37ad412209414
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY044a06a1-74fc-43ff-b136-37ad412209414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-017-42586020017421 BOTTLE in 1 CARTON (58602-017-42) / 60 SPRAY, METERED in 1 BOTTLE1 bottle2024-11-25NoNoCurrent
58602-017-43586020017431 BOTTLE in 1 CARTON (58602-017-43) / 120 SPRAY, METERED in 1 BOTTLE1 bottle2024-05-10NoNoCurrent
58602-017-45586020017451 BOTTLE in 1 CARTON (58602-017-45) / 72 SPRAY, METERED in 1 BOTTLE1 bottle2025-12-16NoNoCurrent
58602-017-46586020017462 BOTTLE in 1 CARTON (58602-017-46) / 72 SPRAY, METERED in 1 BOTTLE2 bottle2025-12-16NoNoCurrent
58602-017-47586020017473 BOTTLE in 1 CARTON (58602-017-47) / 72 SPRAY, METERED in 1 BOTTLE3 bottle2025-12-16NoNoCurrent
58602-017-48586020017481 BOTTLE in 1 CARTON (58602-017-48) / 144 SPRAY, METERED in 1 BOTTLE1 bottle2025-12-16NoNoCurrent
58602-017-49586020017492 BOTTLE in 1 CARTON (58602-017-49) / 144 SPRAY, METERED in 1 BOTTLE2 bottle2025-12-16NoNoCurrent
58602-017-50586020017503 BOTTLE in 1 CARTON (58602-017-50) / 144 SPRAY, METERED in 1 BOTTLE3 bottle2025-12-16NoNoCurrent