FDA.reportPublic FDA data

ADVAIR HFA

Product NDC
0173-0715
11-digit product format
001730715
Labeler code
0173
Product ID
0173-0715_bea52e57-aa75-4dce-8cfb-a163bbc22be2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone propionate and salmeterol xinafoate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
GlaxoSmithKline LLC
Application
NDA021254
Marketing category
NDA
Marketing start
2008-09-29
Substance
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Active strength
45; 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ADVAIR HFA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE PROPIONATE45 ug/1
SALMETEROL XINAFOATE21 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6EW8Q962A5, O2GMZ0LF5W
Rxcui896231, 896235, 896236, 896237, 896239, 896243, 896244, 896245, 896267, 896271, 896272, 896273

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
0173-0715-20ADVAIR HFA120 in 1 INHALERAEROSOL, METERED12037
0173-0715-20ADVAIR HFA1 in 1 CARTONAEROSOL, METERED137
0173-0715-22ADVAIR HFA60 in 1 INHALERAEROSOL, METERED6037
0173-0715-22ADVAIR HFA1 in 1 CARTONAEROSOL, METERED137

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0715-20GM - Gram0173-0715132c5092-6f28-428e-bac3-eec370a2dbe012012-07-24
0173-0715-22GM - Gram0173-07159cde6638-dfd9-46b3-b0a1-1669cbc830b512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5WADVAIR HFA (FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE) AEROSOL, METERED [GLAXOSMITHKLINE LLC]20
SALMETEROL XINAFOATEACTIVE INGREDIENT6EW8Q962A5ADVAIR HFA (FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE) AEROSOL, METERED [GLAXOSMITHKLINE LLC]20
FLUTICASONEACTIVE MOIETYCUT2W21N7UADVAIR HFA (FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE) AEROSOL, METERED [GLAXOSMITHKLINE LLC]20
SALMETEROLACTIVE MOIETY2I4BC502BTADVAIR HFA (FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE) AEROSOL, METERED [GLAXOSMITHKLINE LLC]20
NORFLURANEINACTIVE INGREDIENTDH9E53K1Y8ADVAIR HFA (FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE) AEROSOL, METERED [GLAXOSMITHKLINE LLC]20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0715ADVAIR HFA (FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE) AEROSOL, METERED [GLAXOSMITHKLINE LLC]35Current NDC, Legacy NDC, 4 package rows20250525_dfaca6f9-3277-47b2-319d-1377917cb54c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896245ADVAIR HFA 115/21 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSNdfaca6f9-3277-47b2-319d-1377917cb54c37
896243ADVAIR HFA 115/21 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSNdfaca6f9-3277-47b2-319d-1377917cb54c37
896273ADVAIR HFA 230/21 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSNdfaca6f9-3277-47b2-319d-1377917cb54c37
896271ADVAIR HFA 230/21 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSNdfaca6f9-3277-47b2-319d-1377917cb54c37
896237ADVAIR HFA 45/21 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSNdfaca6f9-3277-47b2-319d-1377917cb54c37
896235ADVAIR HFA 45/21 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSNdfaca6f9-3277-47b2-319d-1377917cb54c37
896244fluticasone propionate/salmeterol 115/21 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSNdfaca6f9-3277-47b2-319d-1377917cb54c37
896239fluticasone propionate/salmeterol 115/21 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSNdfaca6f9-3277-47b2-319d-1377917cb54c37
896272fluticasone propionate/salmeterol 230/21 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSNdfaca6f9-3277-47b2-319d-1377917cb54c37
896267fluticasone propionate/salmeterol 230/21 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSNdfaca6f9-3277-47b2-319d-1377917cb54c37
896236fluticasone propionate/salmeterol 45/21 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSNdfaca6f9-3277-47b2-319d-1377917cb54c37
896231fluticasone propionate/salmeterol 45/21 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSNdfaca6f9-3277-47b2-319d-1377917cb54c37
896237120 ACTUAT fluticasone propionate 0.045 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose Inhaler [Advair]SBDdfaca6f9-3277-47b2-319d-1377917cb54c37
896245120 ACTUAT fluticasone propionate 0.115 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose Inhaler [Advair]SBDdfaca6f9-3277-47b2-319d-1377917cb54c37
896273120 ACTUAT fluticasone propionate 0.23 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose Inhaler [Advair]SBDdfaca6f9-3277-47b2-319d-1377917cb54c37
89623560 ACTUAT fluticasone propionate 0.045 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose Inhaler [Advair]SBDdfaca6f9-3277-47b2-319d-1377917cb54c37
89624360 ACTUAT fluticasone propionate 0.115 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose Inhaler [Advair]SBDdfaca6f9-3277-47b2-319d-1377917cb54c37
89627160 ACTUAT fluticasone propionate 0.23 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose Inhaler [Advair]SBDdfaca6f9-3277-47b2-319d-1377917cb54c37
896236120 ACTUAT fluticasone propionate 0.045 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose InhalerSCDdfaca6f9-3277-47b2-319d-1377917cb54c37
896244120 ACTUAT fluticasone propionate 0.115 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose InhalerSCDdfaca6f9-3277-47b2-319d-1377917cb54c37
896272120 ACTUAT fluticasone propionate 0.23 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose InhalerSCDdfaca6f9-3277-47b2-319d-1377917cb54c37
89623160 ACTUAT fluticasone propionate 0.045 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose InhalerSCDdfaca6f9-3277-47b2-319d-1377917cb54c37
89623960 ACTUAT fluticasone propionate 0.115 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose InhalerSCDdfaca6f9-3277-47b2-319d-1377917cb54c37
89626760 ACTUAT fluticasone propionate 0.23 MG/ACTUAT / salmeterol 0.021 MG/ACTUAT Metered Dose InhalerSCDdfaca6f9-3277-47b2-319d-1377917cb54c37
896243Advair HFA 115/21 (fluticasone propionate 115 MCG / salmeterol 21 MCG (salmeterol 30.45 MCG)) per ACTUAT Metered Dose Inhaler, 60 ACTUATSYdfaca6f9-3277-47b2-319d-1377917cb54c37
896245Advair HFA 115/21 (fluticasone propionate 115 MCG / salmeterol 21 MCG (salmeterol xinafoate 30.45 MCG)) per ACTUAT Metered Dose Inhaler, 120 ACTUATSYdfaca6f9-3277-47b2-319d-1377917cb54c37
896245Advair HFA 115/21 Metered Dose Inhaler, 120 ACTUATSYdfaca6f9-3277-47b2-319d-1377917cb54c37
896243Advair HFA 115/21 Metered Dose Inhaler, 60 ACTUATSYdfaca6f9-3277-47b2-319d-1377917cb54c37
896273Advair HFA 230/21 (fluticasone propionate 230 MCG / salmeterol 21 MCG (salmeterol xinafoate 30.45 MCG)) per ACTUAT Metered Dose Inhaler, 120 ACTUATSYdfaca6f9-3277-47b2-319d-1377917cb54c37
896271Advair HFA 230/21 (fluticasone propionate 230 MCG / salmeterol 21 MCG (salmeterol xinafoate 30.45 MCG)) per ACTUAT Metered Dose Inhaler, 60 ACTUATSYdfaca6f9-3277-47b2-319d-1377917cb54c37
896273Advair HFA 230/21 Metered Dose Inhaler, 120 ACTUATSYdfaca6f9-3277-47b2-319d-1377917cb54c37
896271Advair HFA 230/21 Metered Dose Inhaler, 60 ACTUATSYdfaca6f9-3277-47b2-319d-1377917cb54c37
896235Advair HFA 45/21 (fluticasone propionate 0.045 MG / salmeterol 0.021 MG (salmeterol xinafoate 30.45 MCG)) per ACTUAT Metered Dose Inhaler, 60 ACTUATSYdfaca6f9-3277-47b2-319d-1377917cb54c37
896237Advair HFA 45/21 (fluticasone propionate 45 MCG / salmeterol 21 MCG (salmeterol xinafoate 30.45 MCG)) per ACTUAT Metered Dose Inhaler, 120 ACTUATSYdfaca6f9-3277-47b2-319d-1377917cb54c37
896237Advair HFA 45/21 Metered Dose Inhaler, 120 ACTUATSYdfaca6f9-3277-47b2-319d-1377917cb54c37
896235Advair HFA 45/21 Metered Dose Inhaler, 60 ACTUATSYdfaca6f9-3277-47b2-319d-1377917cb54c37
896236fluticasone propionate 0.045 MG / salmeterol 0.021 MG per ACTUAT Metered Dose Inhaler, 120 ACTUATSYdfaca6f9-3277-47b2-319d-1377917cb54c37
896231fluticasone propionate 0.045 MG / salmeterol 0.021 MG per ACTUAT Metered Dose Inhaler, 60 ACTUATSYdfaca6f9-3277-47b2-319d-1377917cb54c37
896244fluticasone propionate 0.115 MG / salmeterol 0.021 MG per ACTUAT Metered Dose Inhaler, 120 ACTUATSYdfaca6f9-3277-47b2-319d-1377917cb54c37
896239fluticasone propionate 0.115 MG / salmeterol 0.021 MG per ACTUAT Metered Dose Inhaler, 60 ACTUATSYdfaca6f9-3277-47b2-319d-1377917cb54c37
896272fluticasone propionate 0.23 MG / salmeterol 0.021 MG per ACTUAT Metered Dose Inhaler, 120 ACTUATSYdfaca6f9-3277-47b2-319d-1377917cb54c37
896267fluticasone propionate 0.23 MG / salmeterol 0.021 MG per ACTUAT Metered Dose Inhaler, 60 ACTUATSYdfaca6f9-3277-47b2-319d-1377917cb54c37
896244fluticasone propionate 115 MCG / salmeterol 21 MCG (salmeterol xinafoate 30.45 MCG) per ACTUAT Metered Dose Inhaler, 120 ACTUATSYdfaca6f9-3277-47b2-319d-1377917cb54c37
896239fluticasone propionate 115 MCG / salmeterol 21 MCG (salmeterol xinafoate 30.45 MCG) per ACTUAT Metered Dose Inhaler, 60 ACTUATSYdfaca6f9-3277-47b2-319d-1377917cb54c37
896272fluticasone propionate 230 MCG / salmeterol 21 MCG (salmeterol xinafoate 30.45 MCG) per ACTUAT Metered Dose Inhaler, 120 ACTUATSYdfaca6f9-3277-47b2-319d-1377917cb54c37
896267fluticasone propionate 230 MCG / salmeterol 21 MCG (salmeterol xinafoate 30.45 MCG) per ACTUAT Metered Dose Inhaler, 60 ACTUATSYdfaca6f9-3277-47b2-319d-1377917cb54c37
896236fluticasone propionate 45 MCG / salmeterol 21 MCG (salmeterol xinafoate 30.45 MCG) per ACTUAT Metered Dose Inhaler, 120 ACTUATSYdfaca6f9-3277-47b2-319d-1377917cb54c37
896231fluticasone propionate 45 MCG / salmeterol 21 MCG per ACTUAT Metered Dose Inhaler, 60 ACTUATSYdfaca6f9-3277-47b2-319d-1377917cb54c37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0173-0715-20001730715201 INHALER in 1 CARTON (0173-0715-20) / 120 AEROSOL, METERED in 1 INHALER1 inhaler2008-09-290000-00-00NoNoCurrent
0173-0715-22001730715221 INHALER in 1 CARTON (0173-0715-22) / 60 AEROSOL, METERED in 1 INHALER1 inhaler2008-09-290000-00-00NoNoCurrent