FDA.reportPublic FDA data

Fluticasone Propionate

Product NDC
60505-0829
11-digit product format
605050829
Labeler code
60505
Product ID
60505-0829_de4b94c3-9864-33f5-8afe-ec494562de52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Apotex Corp.
Application
ANDA077538
Marketing category
ANDA
Marketing start
2007-09-19
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
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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0829-1Fluticasone Propionate120 in 1 BOTTLE, SPRAYSPRAY, METERED12013
60505-0829-1Fluticasone Propionate1 in 1 CARTONSPRAY, METERED113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0829-1GM - Gram60505-0829c26eff57-5f05-4d4f-84a5-60bef1308e3012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5WFLUTICASONE PROPIONATE SPRAY, METERED [APOTEX CORP.]3
FLUTICASONEACTIVE MOIETYCUT2W21N7UFLUTICASONE PROPIONATE SPRAY, METERED [APOTEX CORP.]3
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7FLUTICASONE PROPIONATE SPRAY, METERED [APOTEX CORP.]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311FLUTICASONE PROPIONATE SPRAY, METERED [APOTEX CORP.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUTICASONE PROPIONATE SPRAY, METERED [APOTEX CORP.]3
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2FLUTICASONE PROPIONATE SPRAY, METERED [APOTEX CORP.]3
PHENYLETHYL ALCOHOLINACTIVE INGREDIENTML9LGA7468FLUTICASONE PROPIONATE SPRAY, METERED [APOTEX CORP.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLUTICASONE PROPIONATE SPRAY, METERED [APOTEX CORP.]3
WATERINACTIVE INGREDIENT059QF0KO0RFLUTICASONE PROPIONATE SPRAY, METERED [APOTEX CORP.]3
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5WFLUTICASONE PROPIONATE SPRAY, METERED [BLENHEIM PHARMACAL, INC.]1
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5WFLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC.]1
FLUTICASONEACTIVE MOIETYCUT2W21N7UFLUTICASONE PROPIONATE SPRAY, METERED [BLENHEIM PHARMACAL, INC.]1
FLUTICASONEACTIVE MOIETYCUT2W21N7UFLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7FLUTICASONE PROPIONATE SPRAY, METERED [BLENHEIM PHARMACAL, INC.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7FLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311FLUTICASONE PROPIONATE SPRAY, METERED [BLENHEIM PHARMACAL, INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311FLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUTICASONE PROPIONATE SPRAY, METERED [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC.]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2FLUTICASONE PROPIONATE SPRAY, METERED [BLENHEIM PHARMACAL, INC.]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2FLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC.]1
PHENYLETHYL ALCOHOLINACTIVE INGREDIENTML9LGA7468FLUTICASONE PROPIONATE SPRAY, METERED [BLENHEIM PHARMACAL, INC.]1
PHENYLETHYL ALCOHOLINACTIVE INGREDIENTML9LGA7468FLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLUTICASONE PROPIONATE SPRAY, METERED [BLENHEIM PHARMACAL, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RFLUTICASONE PROPIONATE SPRAY, METERED [BLENHEIM PHARMACAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RFLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0829FLUTICASONE PROPIONATE SPRAY, METERED [APOTEX CORP.]12Current NDC, Legacy NDC, 2 package rows20240927_3830675d-b45e-fc97-1f73-674b1fc38c80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN3830675d-b45e-fc97-1f73-674b1fc38c8013
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD3830675d-b45e-fc97-1f73-674b1fc38c8013
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY3830675d-b45e-fc97-1f73-674b1fc38c8013
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNd781dd49-ed8d-4204-99ac-a3b632d7640a11
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNe2df3810-3b92-4678-8f62-683c656b1de911
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDd781dd49-ed8d-4204-99ac-a3b632d7640a11
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDe2df3810-3b92-4678-8f62-683c656b1de911
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySYe2df3810-3b92-4678-8f62-683c656b1de911
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySYd781dd49-ed8d-4204-99ac-a3b632d7640a11
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN4916301d-bcc8-4cd1-86b4-7bf0aecfbf6810
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD4916301d-bcc8-4cd1-86b4-7bf0aecfbf6810
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY4916301d-bcc8-4cd1-86b4-7bf0aecfbf6810
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN9c8cf3e5-6d17-4261-b7ca-b14afd027cdd8
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD9c8cf3e5-6d17-4261-b7ca-b14afd027cdd8
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY9c8cf3e5-6d17-4261-b7ca-b14afd027cdd8
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN1d5d5f27-6565-4e7b-9923-faa3d15cb1c46
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD1d5d5f27-6565-4e7b-9923-faa3d15cb1c46
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY1d5d5f27-6565-4e7b-9923-faa3d15cb1c46
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN1bcf25b7-25bc-489e-b5b6-3ae2b3babf6e5
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN76f54eb2-0c12-4981-acbe-baa9c4ee02b65
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD76f54eb2-0c12-4981-acbe-baa9c4ee02b65
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD1bcf25b7-25bc-489e-b5b6-3ae2b3babf6e5
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY1bcf25b7-25bc-489e-b5b6-3ae2b3babf6e5
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY76f54eb2-0c12-4981-acbe-baa9c4ee02b65
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN8b9f7474-8d89-b3e6-e053-2995a90aeddb3
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN2038d86c-ba3f-4029-bb95-44360afa148f3
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD2038d86c-ba3f-4029-bb95-44360afa148f3
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD8b9f7474-8d89-b3e6-e053-2995a90aeddb3
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY2038d86c-ba3f-4029-bb95-44360afa148f3
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY8b9f7474-8d89-b3e6-e053-2995a90aeddb3
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNd1f15a7c-be14-03e4-e053-2995a90a63092
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDd1f15a7c-be14-03e4-e053-2995a90a63092
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySYd1f15a7c-be14-03e4-e053-2995a90a63092
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN504397c5-6f9f-45cc-9cc9-997da0a803641
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN1f3eeb8b-a831-11a7-e063-6294a90ab5ba1
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN13f0f08b-8310-2949-e054-00144ff88e881
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD504397c5-6f9f-45cc-9cc9-997da0a803641
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD13f0f08b-8310-2949-e054-00144ff88e881
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD1f3eeb8b-a831-11a7-e063-6294a90ab5ba1
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY504397c5-6f9f-45cc-9cc9-997da0a803641
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY1f3eeb8b-a831-11a7-e063-6294a90ab5ba1
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY13f0f08b-8310-2949-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-0829-1605050829011 BOTTLE, SPRAY in 1 CARTON (60505-0829-1) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY2007-09-190000-00-00NoNoCurrent