FDA.reportPublic FDA data

Fluticasone Propionate

Product NDC
0054-3270
11-digit product format
000543270
Labeler code
0054
Product ID
0054-3270_5896404a-ec42-414a-8d70-3a4147636278
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA076504
Marketing category
ANDA
Marketing start
2006-02-22
Substance
FLUTICASONE PROPIONATE
Active strength
50 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluticasone Propionate
Listing expiration
2027-12-31

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
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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-3270-99Fluticasone Propionate120 in 1 BOTTLE, GLASSSPRAY, METERED12016
0054-3270-99Fluticasone Propionate1 in 1 CARTONSPRAY, METERED116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-3270-99GM - Gram0054-327051264673-1909-4452-a2dd-c0df1f914cfa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5WFLUTICASONE PROPIONATE SPRAY, METERED [ROXANE LABORATORIES, INC]7
FLUTICASONEACTIVE MOIETYCUT2W21N7UFLUTICASONE PROPIONATE SPRAY, METERED [ROXANE LABORATORIES, INC]7
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7FLUTICASONE PROPIONATE SPRAY, METERED [ROXANE LABORATORIES, INC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUTICASONE PROPIONATE SPRAY, METERED [ROXANE LABORATORIES, INC]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUTICASONE PROPIONATE SPRAY, METERED [ROXANE LABORATORIES, INC]7
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2FLUTICASONE PROPIONATE SPRAY, METERED [ROXANE LABORATORIES, INC]7
PHENYLETHYL ALCOHOLINACTIVE INGREDIENTML9LGA7468FLUTICASONE PROPIONATE SPRAY, METERED [ROXANE LABORATORIES, INC]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLUTICASONE PROPIONATE SPRAY, METERED [ROXANE LABORATORIES, INC]7
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5WFLUTICASONE PROPIONATE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5WFLUTICASONE SPRAY, METERED [DIRECT RX]1
FLUTICASONEACTIVE MOIETYCUT2W21N7UFLUTICASONE SPRAY, METERED [DIRECT RX]1
FLUTICASONEACTIVE MOIETYCUT2W21N7UFLUTICASONE PROPIONATE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
Anhydrous DextroseINACTIVE INGREDIENT5SL0G7R0OKFLUTICASONE SPRAY, METERED [DIRECT RX]1
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7FLUTICASONE SPRAY, METERED [DIRECT RX]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7FLUTICASONE PROPIONATE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311FLUTICASONE SPRAY, METERED [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUTICASONE PROPIONATE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUTICASONE PROPIONATE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2FLUTICASONE PROPIONATE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
PHENETHYL ALCOHOLINACTIVE INGREDIENTML9LGA7468FLUTICASONE PROPIONATE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
Phenylethyl AlcoholINACTIVE INGREDIENTML9LGA7468FLUTICASONE SPRAY, METERED [DIRECT RX]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLUTICASONE PROPIONATE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HFLUTICASONE SPRAY, METERED [DIRECT RX]1
WaterINACTIVE INGREDIENT059QF0KO0RFLUTICASONE SPRAY, METERED [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-3270FLUTICASONE PROPIONATE SPRAY, METERED [HIKMA PHARMACEUTICALS USA INC.]14Current NDC, Legacy NDC, 2 package rows20240417_0d9a521b-8314-437c-8c9f-f6188f1134fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN0d9a521b-8314-437c-8c9f-f6188f1134fe16
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN3b1849e1-bd0b-42e4-a4ac-f156dc18604a16
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD0d9a521b-8314-437c-8c9f-f6188f1134fe16
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD3b1849e1-bd0b-42e4-a4ac-f156dc18604a16
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY0d9a521b-8314-437c-8c9f-f6188f1134fe16
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY3b1849e1-bd0b-42e4-a4ac-f156dc18604a16
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN3c7e3ae6-a78f-4023-a2d4-543615ae25b07
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD3c7e3ae6-a78f-4023-a2d4-543615ae25b07
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY3c7e3ae6-a78f-4023-a2d4-543615ae25b07
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNab8c172b-c369-4372-95f9-dd1a28b3982b6
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDab8c172b-c369-4372-95f9-dd1a28b3982b6
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySYab8c172b-c369-4372-95f9-dd1a28b3982b6
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN0a3447a1-407c-40a8-99bb-7e9a86eb37df4
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNab7529ac-fa19-4be8-9906-8889fa3e83984
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN62aecab5-5cc7-476c-b2b8-111f7e00b1884
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN8761a5e1-a9cb-0622-e053-2a95a90a35044
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDab7529ac-fa19-4be8-9906-8889fa3e83984
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD8761a5e1-a9cb-0622-e053-2a95a90a35044
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD0a3447a1-407c-40a8-99bb-7e9a86eb37df4
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD62aecab5-5cc7-476c-b2b8-111f7e00b1884
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY0a3447a1-407c-40a8-99bb-7e9a86eb37df4
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY8761a5e1-a9cb-0622-e053-2a95a90a35044
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY62aecab5-5cc7-476c-b2b8-111f7e00b1884
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySYab7529ac-fa19-4be8-9906-8889fa3e83984
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNf9edc9b3-12e7-4917-a27c-8dbf6ac654ce1
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN6e2d11f9-94d8-4434-b46b-8e2fcc9276fb1
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDf9edc9b3-12e7-4917-a27c-8dbf6ac654ce1
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD6e2d11f9-94d8-4434-b46b-8e2fcc9276fb1
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY6e2d11f9-94d8-4434-b46b-8e2fcc9276fb1
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySYf9edc9b3-12e7-4917-a27c-8dbf6ac654ce1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0054-3270-99000543270991 BOTTLE, GLASS in 1 CARTON (0054-3270-99) / 120 SPRAY, METERED in 1 BOTTLE, GLASS2006-02-220000-00-00NoNoCurrent