FDA.reportPublic FDA data

Fluticasone Propionate

Product NDC
49035-362
11-digit product format
490350362
Labeler code
49035
Product ID
49035-362_5a0d9074-0bd2-e7b4-d816-399454e9aa37
Type
HUMAN OTC DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Walmart
Application
ANDA208150
Marketing category
ANDA
Marketing start
2017-10-23
Marketing end
2026-10-31
Substance
FLUTICASONE PROPIONATE
Active strength
50 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluticasone Propionate

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-362-01Fluticasone Propionate1 in 1 CARTONSPRAY, METERED111
49035-362-01Fluticasone Propionate60 in 1 BOTTLE, SPRAYSPRAY, METERED6011
49035-362-02Fluticasone Propionate1 in 1 CARTONSPRAY, METERED111
49035-362-03Fluticasone Propionate120 in 1 BOTTLE, SPRAYSPRAY, METERED12011
49035-362-04Fluticasone Propionate1 in 1 CARTONSPRAY, METERED111
49035-362-04Fluticasone Propionate72 in 1 BOTTLE, SPRAYSPRAY, METERED7211
49035-362-05Fluticasone Propionate144 in 1 BOTTLE, SPRAYSPRAY, METERED14411
49035-362-05Fluticasone Propionate1 in 1 CARTONSPRAY, METERED111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-362-04ML - Milliliter49035-3628b5bcd0d-4e0d-4fc0-9279-a0743e06d0a112024-09-09
49035-362-05ML - Milliliter49035-36274c90abe-5ed6-4227-87c8-e0cbe57e462e12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-362FLUTICASONE PROPIONATE SPRAY, METERED [WALMART]10Current NDC, Legacy NDC, 8 package rows20241004_8616944c-a684-085a-7106-cf034e3f6f4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN8616944c-a684-085a-7106-cf034e3f6f4d11
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD8616944c-a684-085a-7106-cf034e3f6f4d11
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY8616944c-a684-085a-7106-cf034e3f6f4d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49035-362-01490350362011 BOTTLE, SPRAY in 1 CARTON (49035-362-01) > 60 SPRAY, METERED in 1 BOTTLE, SPRAY2017-10-232024-04-28NoNoCurrent
49035-362-02490350362021 BOTTLE, SPRAY in 1 CARTON (49035-362-02) > 120 SPRAY, METERED in 1 BOTTLE, SPRAY (49035-362-03) 2021-02-262024-08-05NoNoCurrent
49035-362-0349035036203120 in 1 BOTTLE, SPRAYHistorical
49035-362-04490350362041 BOTTLE, SPRAY in 1 CARTON (49035-362-04) > 72 SPRAY, METERED in 1 BOTTLE, SPRAY2021-07-260000-00-00NoNoCurrent
49035-362-05490350362051 BOTTLE, SPRAY in 1 CARTON (49035-362-05) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY2021-07-262026-10-31NoNoCurrent