Fluticasone Propionate

Product NDC
53002-7691
11-digit product format
530027691
Labeler code
53002
Product ID
53002-7691_ad6646bc-2f49-4147-a6d2-b2aae222c4d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA077538
Marketing category
ANDA
Marketing start
2007-09-19
Marketing end
0000-00-00
Substance
FLUTICASONE PROPIONATE
Active strength
50 ug/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-7691-12025-01-30C16284748780-19d75b9d0-1d17-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FLUTICASONE PROPIONATE nasal spray safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE nasal spray . FLUTICASONE PROPIONATE nasal spray, USP Initial U.S. Approval: 1994
53002-7691-12023-06-07C16284748780-19d75b9d0-1d17-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FLUTICASONE PROPIONATE nasal spray safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE nasal spray . FLUTICASONE PROPIONATE nasal spray, USP Initial U.S. Approval: 1994
53002-7691-12023-01-30C16284748780-19d75b9d0-1d17-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FLUTICASONE PROPIONATE nasal spray safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE nasal spray . FLUTICASONE PROPIONATE nasal spray, USP Initial U.S. Approval: 1994
53002-7691-12020-12-17C16284748780-19d75b9d0-1d17-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FLUTICASONE PROPIONATE nasal spray safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE nasal spray . FLUTICASONE PROPIONATE nasal spray, USP Initial U.S. Approval: 1994
53002-7691-12020-01-31C16284748780-19d75b9d0-1d17-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use FLUTICASONE PROPIONATE nasal spray safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE nasal spray . FLUTICASONE PROPIONATE nasal spray, USP Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-7691-1Fluticasone Propionate1 in 1 CARTONSPRAY, METERED15
53002-7691-1Fluticasone Propionate120 in 1 BOTTLE, SPRAYSPRAY, METERED1205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-7691FLUTICASONE PROPIONATE SPRAY, METERED [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 2 package rows20230609_76f54eb2-0c12-4981-acbe-baa9c4ee02b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 50 MCG/ACTUAT Metered Dose Nasal SpraySY76f54eb2-0c12-4981-acbe-baa9c4ee02b65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-7691-1530027691011 BOTTLE, SPRAY in 1 CARTON (53002-7691-1) > 120 SPRAY, METERED in 1 BOTTLE, SPRAY2018-10-010000-00-00NoNoCurrent