FDA.reportPublic FDA data

ADVAIR

Product NDC
50090-0730
11-digit product format
500900730
Labeler code
50090
Product ID
50090-0730_38acede8-b21d-4feb-ac87-48b837fee6a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone propionate and salmeterol
Dosage form
POWDER
Route
RESPIRATORY (INHALATION)
Labeler
A-S Medication Solutions
Application
NDA021077
Marketing category
NDA
Marketing start
2001-02-28
Substance
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Active strength
100; 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE PROPIONATE100 ug/1
SALMETEROL XINAFOATE50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO2GMZ0LF5W, 6EW8Q962A5
Rxcui896184, 896185, 896209, 896212, 896228, 896229

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0730-02021-02-19C16284748780-19d75b9d0-c694-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ADVAIR DISKUS safely and effectively. See full prescribing information for ADVAIR DISKUS. ADVAIR DISKUS (fluticasone propionate and salmeterol inhalation powder), for oral inhalation use Initial U.S. Approval: 2000
50090-0730-02021-02-19C16284748780-19d75b9d0-c694-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ADVAIR DISKUS safely and effectively. See full prescribing information for ADVAIR DISKUS. ADVAIR DISKUS (fluticasone propionate and salmeterol inhalation powder), for oral inhalation use Initial U.S. Approval: 2000
50090-0730-02021-02-19C16284748780-19d75b9d0-c694-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ADVAIR DISKUS safely and effectively. See full prescribing information for ADVAIR DISKUS. ADVAIR DISKUS (fluticasone propionate and salmeterol inhalation powder), for oral inhalation use Initial U.S. Approval: 2000
50090-0730-02020-01-31C16284748780-19d75b9d0-c694-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ADVAIR DISKUS safely and effectively. See full prescribing information for ADVAIR DISKUS. ADVAIR DISKUS (fluticasone propionate and salmeterol inhalation powder), for oral inhalation use Initial U.S. Approval: 2000
50090-0730-02020-01-31C16284748780-19d75b9d0-c694-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ADVAIR DISKUS safely and effectively. See full prescribing information for ADVAIR DISKUS. ADVAIR DISKUS (fluticasone propionate and salmeterol inhalation powder), for oral inhalation use Initial U.S. Approval: 2000
50090-0730-02020-01-31C16284748780-19d75b9d0-c694-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ADVAIR DISKUS safely and effectively. See full prescribing information for ADVAIR DISKUS. ADVAIR DISKUS (fluticasone propionate and salmeterol inhalation powder), for oral inhalation use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0730-0ADVAIRDISKUS1 in 1 CARTONPOWDER137
50090-0730-0ADVAIRDISKUS60 in 1 INHALERPOWDER6037

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0730-0EA - Each50090-073090adb169-e1bf-4c58-a4b0-c86b4da8255512018-10-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896185ADVAIR DISKUS 100/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSNcf306656-0d4c-4edd-9d6a-3471f99484e637
896212ADVAIR DISKUS 250/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSNcf306656-0d4c-4edd-9d6a-3471f99484e637
896229ADVAIR DISKUS 500/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSNcf306656-0d4c-4edd-9d6a-3471f99484e637
896184fluticasone propionate/salmeterol 100/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSNcf306656-0d4c-4edd-9d6a-3471f99484e637
896209fluticasone propionate/salmeterol 250/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSNcf306656-0d4c-4edd-9d6a-3471f99484e637
896228fluticasone propionate/salmeterol 500/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSNcf306656-0d4c-4edd-9d6a-3471f99484e637
89618560 ACTUAT fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Advair]SBDcf306656-0d4c-4edd-9d6a-3471f99484e637
89621260 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Advair]SBDcf306656-0d4c-4edd-9d6a-3471f99484e637
89622960 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Advair]SBDcf306656-0d4c-4edd-9d6a-3471f99484e637
89618460 ACTUAT fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCDcf306656-0d4c-4edd-9d6a-3471f99484e637
89620960 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCDcf306656-0d4c-4edd-9d6a-3471f99484e637
89622860 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCDcf306656-0d4c-4edd-9d6a-3471f99484e637
896185Advair Diskus 100/50 (fluticasone propionate 100 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG)) per ACTUAT Dry Powder Inhaler, 60 ACTUATSYcf306656-0d4c-4edd-9d6a-3471f99484e637
896185Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUATSYcf306656-0d4c-4edd-9d6a-3471f99484e637
896212Advair Diskus 250/50 (fluticasone propionate 250 MCG / salmeterol 50 MCG (as salmeterol xinafoate 72.5 MCG)) per ACTUAT Dry Powder Inhaler, 60 ACTUATSYcf306656-0d4c-4edd-9d6a-3471f99484e637
896212Advair Diskus 250/50 Dry Powder Inhaler, 60 ACTUATSYcf306656-0d4c-4edd-9d6a-3471f99484e637
896229Advair Diskus 500/50 (fluticasone propionate 500 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG)) per ACTUAT Dry Powder Inhaler, 60 ACTUATSYcf306656-0d4c-4edd-9d6a-3471f99484e637
896229Advair Diskus 500/50 Dry Powder Inhaler, 60 ACTUATSYcf306656-0d4c-4edd-9d6a-3471f99484e637
896184fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler, 60 ACTUATSYcf306656-0d4c-4edd-9d6a-3471f99484e637
896209fluticasone propionate 0.25 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUATSYcf306656-0d4c-4edd-9d6a-3471f99484e637
896228fluticasone propionate 0.5 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUATSYcf306656-0d4c-4edd-9d6a-3471f99484e637
896184fluticasone propionate 100 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUATSYcf306656-0d4c-4edd-9d6a-3471f99484e637
896209fluticasone propionate 250 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUATSYcf306656-0d4c-4edd-9d6a-3471f99484e637
896228fluticasone propionate 500 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUATSYcf306656-0d4c-4edd-9d6a-3471f99484e637

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-0730-0500900730001 INHALER in 1 CARTON (50090-0730-0) / 60 POWDER in 1 INHALER1 inhaler2014-11-28NoNoCurrent