FDA.reportPublic FDA data

Fluticasone Propionate and Salmeterol

Product NDC
66993-585
11-digit product format
669930585
Labeler code
66993
Product ID
66993-585_0318e892-0db1-4a82-a649-9e530a2d1d05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone propionate and salmeterol
Dosage form
POWDER
Route
RESPIRATORY (INHALATION)
Labeler
Prasco Laboratories
Application
NDA021077
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-02-08
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
Fluticasone Propionate and Salmeterol
Brand name suffix
DISKUS
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO2GMZ0LF5W, 6EW8Q962A5

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
66993-585-97Fluticasone Propionate and SalmeterolDISKUS1 in 1 CARTONPOWDER114
66993-585-97Fluticasone Propionate and SalmeterolDISKUS60 in 1 INHALERPOWDER6014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-585-97EA - Each66993-585676ae06a-c53b-425d-956f-9832b77fd33b12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-585FLUTICASONE PROPIONATE AND SALMETEROL DISKUS (FLUTICASONE PROPIONATE AND SALMETEROL) POWDER [PRASCO LABORATORIES]13Current NDC, Legacy NDC, 2 package rows20240711_6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896184fluticasone propionate/salmeterol 100/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc14
896209fluticasone propionate/salmeterol 250/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc14
896228fluticasone propionate/salmeterol 500/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc14
89618460 ACTUAT fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCD6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc14
89620960 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCD6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc14
89622860 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCD6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc14
896184fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler, 60 ACTUATSY6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc14
896209fluticasone propionate 0.25 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUATSY6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc14
896228fluticasone propionate 0.5 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUATSY6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc14
896184fluticasone propionate 100 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUATSY6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc14
896209fluticasone propionate 250 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUATSY6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc14
896228fluticasone propionate 500 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUATSY6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc14
896209fluticasone propionate/salmeterol 250/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN9e237635-6975-4930-9ce1-051d9e3bf61512
89620960 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCD9e237635-6975-4930-9ce1-051d9e3bf61512
896209fluticasone propionate 0.25 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUATSY9e237635-6975-4930-9ce1-051d9e3bf61512
896209fluticasone propionate 250 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUATSY9e237635-6975-4930-9ce1-051d9e3bf61512
896209fluticasone propionate/salmeterol 250/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN6915bd5d-b792-4b1b-8221-7eeb0a8638ba3
89620960 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCD6915bd5d-b792-4b1b-8221-7eeb0a8638ba3
896209fluticasone propionate 0.25 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUATSY6915bd5d-b792-4b1b-8221-7eeb0a8638ba3
896209fluticasone propionate 250 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUATSY6915bd5d-b792-4b1b-8221-7eeb0a8638ba3
896209fluticasone propionate/salmeterol 250/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN1ce604aa-2535-4a3c-a64d-092f5d4f81942
89620960 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCD1ce604aa-2535-4a3c-a64d-092f5d4f81942
896209fluticasone propionate 0.25 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUATSY1ce604aa-2535-4a3c-a64d-092f5d4f81942
896209fluticasone propionate 250 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUATSY1ce604aa-2535-4a3c-a64d-092f5d4f81942

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66993-585-97669930585971 INHALER in 1 CARTON (66993-585-97) / 60 POWDER in 1 INHALER1 inhaler2019-02-080000-00-00NoNoCurrent