Fluticasone Furoate and Vilanterol

Product NDC
66993-135
11-digit product format
669930135
Labeler code
66993
Product ID
66993-135_18928e94-a9ff-44a6-a65e-c6f8c21c815c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone furoate and vilanterol
Dosage form
POWDER
Route
RESPIRATORY (INHALATION)
Labeler
Prasco Laboratories
Application
NDA204275
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2022-05-23
Substance
FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
Active strength
100; 25 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
Fluticasone Furoate and Vilanterol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE FUROATE100 ug/1
VILANTEROL TRIFENATATE25 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii40AHO2C6DG, JS86977WNV

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
c982201d-72cb-462f-9e02-902ec0d4a295Product name120181030
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
66993-135-97Fluticasone Furoate and Vilanterol1 in 1 TRAYPOWDER16
66993-135-97Fluticasone Furoate and Vilanterol1 in 1 CARTONPOWDER16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-135-97EA - Each66993-1358bb243dd-8629-4c1e-8136-dedf69b1a58012022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-135FLUTICASONE FUROATE AND VILANTEROL POWDER [PRASCO LABORATORIES]6Current NDC, Legacy NDC, 2 package rows20250525_3a761487-c300-451a-8537-3196c00c11b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1424889fluticasone furoate/vilanterol 100/25 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSN3a761487-c300-451a-8537-3196c00c11b56
1648788fluticasone furoate/vilanterol 200/25 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSN3a761487-c300-451a-8537-3196c00c11b56
142488930 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder InhalerSCD3a761487-c300-451a-8537-3196c00c11b56
164878830 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder InhalerSCD3a761487-c300-451a-8537-3196c00c11b56
1648788fluticasone furoate 200 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT) Dry Powder Inhaler, 30 ACTUATSY3a761487-c300-451a-8537-3196c00c11b56
1648788fluticasone furoate/vilanterol 200/25 MCG/INHAL Dry Powder Inhaler, 30 BlistersSY3a761487-c300-451a-8537-3196c00c11b56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66993-135-97669930135971 TRAY in 1 CARTON (66993-135-97) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER1 tray2022-05-230000-00-00NoNoCurrent