FDA.reportPublic FDA data

Wixela Inhub

Product NDC
0378-9321
11-digit product format
003789321
Labeler code
0378
Product ID
0378-9321_03d33612-03b4-4a2c-ba86-47816db363ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone propionate and salmeterol
Dosage form
POWDER
Route
RESPIRATORY (INHALATION)
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA208891
Marketing category
ANDA
Marketing start
2019-02-11
Substance
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Active strength
250; 50 ug/1; ug/1
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Wixela Inhub
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE PROPIONATE250 ug/1
SALMETEROL XINAFOATE50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6EW8Q962A5, O2GMZ0LF5W
Rxcui896184, 896209, 896228, 2110510, 2110513, 2110516

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
811691fa-281f-6d95-fb49-e2337fb2e146Product 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
0378-9321-32Wixela Inhub1 in 1 CARTONPOWDER16
0378-9321-32Wixela Inhub60 in 1 INHALERPOWDER606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-9321-32EA - Each0378-9321ba679e43-d497-4e1d-ab25-fed882cc6d0412019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-9321WIXELA INHUB (FLUTICASONE PROPIONATE AND SALMETEROL) POWDER [MYLAN PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 2 package rows20220911_3beef422-8a07-4a45-9ba6-414511e4b7e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896209fluticasone propionate/salmeterol 250/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN6a5e28ef-3bbb-43a6-b599-499b3c6076c9100
2110513Wixela Inhub 250/50 MCG/INHAL Dry Powder Inhaler, 60 ActuationsPSN6a5e28ef-3bbb-43a6-b599-499b3c6076c9100
211051360 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Wixela]SBD6a5e28ef-3bbb-43a6-b599-499b3c6076c9100
89620960 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCD6a5e28ef-3bbb-43a6-b599-499b3c6076c9100
896209fluticasone propionate 0.25 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUATSY6a5e28ef-3bbb-43a6-b599-499b3c6076c9100
896209fluticasone propionate 250 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUATSY6a5e28ef-3bbb-43a6-b599-499b3c6076c9100
2110513Wixela Inhub 250/50 MCG/INHAL Dry Powder Inhaler, 60 ActuationsSY6a5e28ef-3bbb-43a6-b599-499b3c6076c9100
896184fluticasone propionate/salmeterol 100/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN3beef422-8a07-4a45-9ba6-414511e4b7e26
896209fluticasone propionate/salmeterol 250/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN3beef422-8a07-4a45-9ba6-414511e4b7e26
896228fluticasone propionate/salmeterol 500/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN3beef422-8a07-4a45-9ba6-414511e4b7e26
2110510Wixela Inhub 100/50 MCG/INHAL Dry Powder Inhaler, 60 ActuationsPSN3beef422-8a07-4a45-9ba6-414511e4b7e26
2110513Wixela Inhub 250/50 MCG/INHAL Dry Powder Inhaler, 60 ActuationsPSN3beef422-8a07-4a45-9ba6-414511e4b7e26
2110516Wixela Inhub 500/50 MCG/INHAL Dry Powder Inhaler, 60 ActuationsPSN3beef422-8a07-4a45-9ba6-414511e4b7e26
211051060 ACTUAT fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Wixela]SBD3beef422-8a07-4a45-9ba6-414511e4b7e26
211051360 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Wixela]SBD3beef422-8a07-4a45-9ba6-414511e4b7e26
211051660 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Wixela]SBD3beef422-8a07-4a45-9ba6-414511e4b7e26
89618460 ACTUAT fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCD3beef422-8a07-4a45-9ba6-414511e4b7e26
89620960 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCD3beef422-8a07-4a45-9ba6-414511e4b7e26
89622860 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCD3beef422-8a07-4a45-9ba6-414511e4b7e26
896184fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler, 60 ACTUATSY3beef422-8a07-4a45-9ba6-414511e4b7e26
896209fluticasone propionate 0.25 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUATSY3beef422-8a07-4a45-9ba6-414511e4b7e26
896228fluticasone propionate 0.5 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUATSY3beef422-8a07-4a45-9ba6-414511e4b7e26
896184fluticasone propionate 100 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUATSY3beef422-8a07-4a45-9ba6-414511e4b7e26
896209fluticasone propionate 250 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUATSY3beef422-8a07-4a45-9ba6-414511e4b7e26
896228fluticasone propionate 500 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUATSY3beef422-8a07-4a45-9ba6-414511e4b7e26
2110510Wixela Inhub 100/50 MCG/INHAL Dry Powder Inhaler, 60 ActuationsSY3beef422-8a07-4a45-9ba6-414511e4b7e26
2110513Wixela Inhub 250/50 MCG/INHAL Dry Powder Inhaler, 60 ActuationsSY3beef422-8a07-4a45-9ba6-414511e4b7e26
2110516Wixela Inhub 500/50 MCG/INHAL Dry Powder Inhaler, 60 ActuationsSY3beef422-8a07-4a45-9ba6-414511e4b7e26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-9321-32003789321321 INHALER in 1 CARTON (0378-9321-32) / 60 POWDER in 1 INHALER1 inhaler2019-02-110000-00-00NoNoCurrent