FDA.reportPublic FDA data

Fluticasone Propionate

Product NDC
50383-700
11-digit product format
503830700
Labeler code
50383
Product ID
50383-700_4f61c3c9-e855-4c87-a257-ed2860c866e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Akorn
Application
ANDA077570
Marketing category
ANDA
Marketing start
2008-01-16
Marketing end
0000-00-00
Substance
FLUTICASONE PROPIONATE
Active strength
50 ug/.1g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50383-700-092025-09-10C16284748780-11030e365-6931-111a-e063-dadaa90a10e2b7ea1841-2fb1-48c8-86f9-639893fd1a84
50383-700-162025-09-10C16284748780-11030e365-6931-111a-e063-dadaa90a10e2b7ea1841-2fb1-48c8-86f9-639893fd1a84
50383-700-092024-01-30C16284748780-11030e365-6931-111a-e063-dadaa90a10e2b7ea1841-2fb1-48c8-86f9-639893fd1a84
50383-700-162024-01-30C16284748780-11030e365-6931-111a-e063-dadaa90a10e2b7ea1841-2fb1-48c8-86f9-639893fd1a84

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-700-16GM - Gram50383-700044f5ac8-38f6-4ecd-85ec-913f0e660cb112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5WFLUTICASONE PROPIONATE SPRAY, METERED [HI-TECH PHARMACAL CO., INC.]6
FLUTICASONEACTIVE MOIETYCUT2W21N7UFLUTICASONE PROPIONATE SPRAY, METERED [HI-TECH PHARMACAL CO., INC.]6
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7FLUTICASONE PROPIONATE SPRAY, METERED [HI-TECH PHARMACAL CO., INC.]6
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311FLUTICASONE PROPIONATE SPRAY, METERED [HI-TECH PHARMACAL CO., INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUTICASONE PROPIONATE SPRAY, METERED [HI-TECH PHARMACAL CO., INC.]6
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2FLUTICASONE PROPIONATE SPRAY, METERED [HI-TECH PHARMACAL CO., INC.]6
PHENYLETHYL ALCOHOLINACTIVE INGREDIENTML9LGA7468FLUTICASONE PROPIONATE SPRAY, METERED [HI-TECH PHARMACAL CO., INC.]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLUTICASONE PROPIONATE SPRAY, METERED [HI-TECH PHARMACAL CO., INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RFLUTICASONE PROPIONATE SPRAY, METERED [HI-TECH PHARMACAL CO., INC.]6
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5WFLUTICASONE PROPIONATE SPRAY, METERED [UNIT DOSE SERVICES]2
FLUTICASONEACTIVE MOIETYCUT2W21N7UFLUTICASONE PROPIONATE SPRAY, METERED [UNIT DOSE SERVICES]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7FLUTICASONE PROPIONATE SPRAY, METERED [UNIT DOSE SERVICES]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311FLUTICASONE PROPIONATE SPRAY, METERED [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUTICASONE PROPIONATE SPRAY, METERED [UNIT DOSE SERVICES]2
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2FLUTICASONE PROPIONATE SPRAY, METERED [UNIT DOSE SERVICES]2
PHENYLETHYL ALCOHOLINACTIVE INGREDIENTML9LGA7468FLUTICASONE PROPIONATE SPRAY, METERED [UNIT DOSE SERVICES]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLUTICASONE PROPIONATE SPRAY, METERED [UNIT DOSE SERVICES]2
WATERINACTIVE INGREDIENT059QF0KO0RFLUTICASONE PROPIONATE SPRAY, METERED [UNIT DOSE SERVICES]2
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5WFLUTICASONE SPRAY, METERED [DIRECT RX]1
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5WFLUTICASONE PROPIONATE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5WFLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC]1
FLUTICASONEACTIVE MOIETYCUT2W21N7UFLUTICASONE SPRAY, METERED [DIRECT RX]1
FLUTICASONEACTIVE MOIETYCUT2W21N7UFLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC]1
FLUTICASONEACTIVE MOIETYCUT2W21N7UFLUTICASONE PROPIONATE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1
Anhydrous DextroseINACTIVE INGREDIENT5SL0G7R0OKFLUTICASONE SPRAY, METERED [DIRECT RX]1
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7FLUTICASONE SPRAY, METERED [DIRECT RX]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7FLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7FLUTICASONE PROPIONATE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311FLUTICASONE SPRAY, METERED [DIRECT RX]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311FLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311FLUTICASONE PROPIONATE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUTICASONE PROPIONATE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2FLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2FLUTICASONE PROPIONATE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1
PHENETHYL ALCOHOLINACTIVE INGREDIENTML9LGA7468FLUTICASONE PROPIONATE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1
Phenylethyl AlcoholINACTIVE INGREDIENTML9LGA7468FLUTICASONE SPRAY, METERED [DIRECT RX]1
PHENYLETHYL ALCOHOLINACTIVE INGREDIENTML9LGA7468FLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC]1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HFLUTICASONE SPRAY, METERED [DIRECT RX]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLUTICASONE PROPIONATE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1
WaterINACTIVE INGREDIENT059QF0KO0RFLUTICASONE SPRAY, METERED [DIRECT RX]1
WATERINACTIVE INGREDIENT059QF0KO0RFLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RFLUTICASONE PROPIONATE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-700FLUTICASONE PROPIONATE SPRAY, METERED [AKORN]12Legacy NDC20220315_b7ea1841-2fb1-48c8-86f9-639893fd1a84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN532c9b61-9e3f-461b-87c9-9d6b71f6d2e210
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD532c9b61-9e3f-461b-87c9-9d6b71f6d2e210
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY532c9b61-9e3f-461b-87c9-9d6b71f6d2e210
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN3e710670-b72c-4a84-8c52-3ebae8783a326
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD3e710670-b72c-4a84-8c52-3ebae8783a326
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY3e710670-b72c-4a84-8c52-3ebae8783a326
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNab7529ac-fa19-4be8-9906-8889fa3e83984
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN6117a976-f340-4922-943e-237d1e8ec6f94
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN5e1d9e90-fbe5-1ce9-e053-2a91aa0a89b44
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDab7529ac-fa19-4be8-9906-8889fa3e83984
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD6117a976-f340-4922-943e-237d1e8ec6f94
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD5e1d9e90-fbe5-1ce9-e053-2a91aa0a89b44
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY5e1d9e90-fbe5-1ce9-e053-2a91aa0a89b44
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY6117a976-f340-4922-943e-237d1e8ec6f94
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySYab7529ac-fa19-4be8-9906-8889fa3e83984
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN75049554-64ca-4efa-b8d1-13cf31d0ff902
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNe709c834-61a5-4797-a8ef-0d5aa990d1362
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDe709c834-61a5-4797-a8ef-0d5aa990d1362
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD75049554-64ca-4efa-b8d1-13cf31d0ff902
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySYe709c834-61a5-4797-a8ef-0d5aa990d1362
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY75049554-64ca-4efa-b8d1-13cf31d0ff902
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN8ebff74d-0bf9-44cf-a309-25aa85041f991
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN155d0f79-86c2-4096-97f3-5d82762ddc2e1
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD8ebff74d-0bf9-44cf-a309-25aa85041f991
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD155d0f79-86c2-4096-97f3-5d82762ddc2e1
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY8ebff74d-0bf9-44cf-a309-25aa85041f991
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY155d0f79-86c2-4096-97f3-5d82762ddc2e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50383-700-09503830700091 BOTTLE, PUMP in 1 BOTTLE, PUMP (50383-700-09) > 9 g in 1 BOTTLE, PUMP2016-01-080000-00-00NoNoCurrent
50383-700-16503830700161 BOTTLE, PUMP in 1 CARTON (50383-700-16) > 16 g in 1 BOTTLE, PUMP2008-01-160000-00-00NoNoCurrent