FDA.reportPublic FDA data

XHANCE

Product NDC
71143-375
11-digit product format
711430375
Labeler code
71143
Product ID
71143-375_4650025f-0f79-6a7b-e063-6294a90ab7f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
OptiNose US, Inc.
Application
NDA209022
Marketing category
NDA
Marketing start
2017-10-03
Marketing end
2028-07-31
Substance
FLUTICASONE PROPIONATE
Active strength
93 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
XHANCE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE PROPIONATE93 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO2GMZ0LF5W
Rxcui1946583, 1946589

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
71143-375-01XHANCE120 in 1 BOTTLESPRAY, METERED12018
71143-375-01XHANCE1 in 1 CARTONSPRAY, METERED118
71143-375-98XHANCE28 in 1 BOTTLESPRAY, METERED2818
71143-375-98XHANCE1 in 1 CARTONSPRAY, METERED118
71143-375-99XHANCE1 in 1 CARTONSPRAY, METERED118
71143-375-99XHANCE120 in 1 BOTTLESPRAY, METERED12018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71143-375-01ML - Milliliter71143-375ebe6c1f8-467a-4e16-ae6b-b5293ff7829c12017-11-06
71143-375-99ML - Milliliter71143-37536911206-afb3-4a17-bdf5-e34130b56a9a12026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71143-375XHANCE (FLUTICASONE PROPIONATE) SPRAY, METERED [OPTINOSE US, INC.]16Current NDC, Legacy NDC, 6 package rows20241103_c79bbb9f-e483-4093-8c92-ea978e7bf278.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1946583fluticasone propionate 93 MCG/ACTUAT Metered Dose Nasal SprayPSNc79bbb9f-e483-4093-8c92-ea978e7bf27818
1946589XHANCE 93 MCG/ACTUAT Metered Dose Nasal SprayPSNc79bbb9f-e483-4093-8c92-ea978e7bf27818
1946589fluticasone propionate 0.093 MG/ACTUAT Metered Dose Nasal Spray [Xhance]SBDc79bbb9f-e483-4093-8c92-ea978e7bf27818
1946583fluticasone propionate 0.093 MG/ACTUAT Metered Dose Nasal SpraySCDc79bbb9f-e483-4093-8c92-ea978e7bf27818
1946583fluticasone propionate 93 MCG/ACTUAT Metered Dose Nasal SpraySYc79bbb9f-e483-4093-8c92-ea978e7bf27818
1946589Xhance 0.093 MG/ACTUAT Metered Dose Nasal SpraySYc79bbb9f-e483-4093-8c92-ea978e7bf27818
1946589Xhance 93 MCG/ACTUAT Metered Dose Nasal SpraySYc79bbb9f-e483-4093-8c92-ea978e7bf27818

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71143-375-01711430375011 BOTTLE in 1 CARTON (71143-375-01) / 120 SPRAY, METERED in 1 BOTTLE1 bottle2017-10-032028-07-31NoNoCurrent
71143-375-98711430375981 BOTTLE in 1 CARTON (71143-375-98) / 28 SPRAY, METERED in 1 BOTTLE1 bottle2019-03-012027-07-31YesNoCurrent
71143-375-99711430375991 BOTTLE in 1 CARTON (71143-375-99) > 120 SPRAY, METERED in 1 BOTTLE1 bottle2017-10-030000-00-00YesNoCurrent