FDA.reportPublic FDA data

ADVAIR HFA

Product NDC
50090-4504
11-digit product format
500904504
Labeler code
50090
Product ID
50090-4504_923fa14e-5eb0-42bc-bcb1-a57e952b37b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone propionate and salmeterol xinafoate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
A-S Medication Solutions
Application
NDA021254
Marketing category
NDA
Marketing start
2008-09-29
Substance
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Active strength
115; 21 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
ADVAIR HFA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE PROPIONATE115 ug/1
SALMETEROL XINAFOATE21 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO2GMZ0LF5W, 6EW8Q962A5
Rxcui896244, 896245

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
50090-4504-0ADVAIR HFA1 in 1 CARTONAEROSOL, METERED113
50090-4504-0ADVAIR HFA120 in 1 INHALERAEROSOL, METERED12013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4504-0GM - Gram50090-450493912692-1f60-4283-8b87-cde39e33847b12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4504ADVAIR HFA (FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE) AEROSOL, METERED [A-S MEDICATION SOLUTIONS]11Current NDC, 2 package rows20240627_223fd5d4-3bd2-4e45-b72e-699438c32206.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896245ADVAIR HFA 115/21 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSN223fd5d4-3bd2-4e45-b72e-699438c3220613
896244fluticasone propionate/salmeterol 115/21 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSN223fd5d4-3bd2-4e45-b72e-699438c3220613
896245120 ACTUAT fluticasone propionate 0.115 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose Inhaler [Advair]SBD223fd5d4-3bd2-4e45-b72e-699438c3220613
896244120 ACTUAT fluticasone propionate 0.115 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose InhalerSCD223fd5d4-3bd2-4e45-b72e-699438c3220613
896245Advair HFA 115/21 (fluticasone propionate 115 MCG / salmeterol 21 MCG (salmeterol xinafoate 30.45 MCG)) per ACTUAT Metered Dose Inhaler, 120 ACTUATSY223fd5d4-3bd2-4e45-b72e-699438c3220613
896245Advair HFA 115/21 Metered Dose Inhaler, 120 ACTUATSY223fd5d4-3bd2-4e45-b72e-699438c3220613
896244fluticasone propionate 0.115 MG / salmeterol 0.021 MG per ACTUAT Metered Dose Inhaler, 120 ACTUATSY223fd5d4-3bd2-4e45-b72e-699438c3220613
896244fluticasone propionate 115 MCG / salmeterol 21 MCG (salmeterol xinafoate 30.45 MCG) per ACTUAT Metered Dose Inhaler, 120 ACTUATSY223fd5d4-3bd2-4e45-b72e-699438c3220613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-4504-0500904504001 INHALER in 1 CARTON (50090-4504-0) / 120 AEROSOL, METERED in 1 INHALER1 inhaler2019-09-04NoNoHistorical