FDA.reportPublic FDA data

ADVAIR

Product NDC
21695-197
11-digit product format
216950197
Labeler code
21695
Product ID
21695-197_9e0bdea8-df9b-4873-b24b-919cebff5edd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone propionate and salmeterol
Dosage form
POWDER
Route
ORAL; RESPIRATORY (INHALATION)
Labeler
Rebel Distributors Corp.
Application
NDA021077
Marketing category
NDA
Marketing start
2001-03-05
Marketing end
0000-00-00
Substance
SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE
Active strength
50 ug/1; ug/1
Pharmacologic classes
Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
21695-197-012019-09-24C16284748780-1934fe258-47b2-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use ADVAIR DISKUS safely and effectively. See full prescribing information for ADVAIR DISKUS. ADVAIR DISKUS 100/50 (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder) ADVAIR DISKUS 250/50 (fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder) ADVAIR DISKUS 500/50 (fluticasone propionate 500 mcg and salmeterol 50 mcg inhalation powder) FOR ORAL INHALATION Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-197-01ADVAIRDISKUS60 in 1 INHALERPOWDER601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-197-01EA - Each21695-1979b843722-1712-4d21-8778-02d3a13e592712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5WADVAIR DISKUS (FLUTICASONE PROPIONATE AND SALMETEROL) POWDER [REBEL DISTRIBUTORS CORP.]1
SALMETEROL XINAFOATEACTIVE INGREDIENT6EW8Q962A5ADVAIR DISKUS (FLUTICASONE PROPIONATE AND SALMETEROL) POWDER [REBEL DISTRIBUTORS CORP.]1
FLUTICASONEACTIVE MOIETYCUT2W21N7UADVAIR DISKUS (FLUTICASONE PROPIONATE AND SALMETEROL) POWDER [REBEL DISTRIBUTORS CORP.]1
SALMETEROLACTIVE MOIETY2I4BC502BTADVAIR DISKUS (FLUTICASONE PROPIONATE AND SALMETEROL) POWDER [REBEL DISTRIBUTORS CORP.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GADVAIR DISKUS (FLUTICASONE PROPIONATE AND SALMETEROL) POWDER [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-197ADVAIR DISKUS (FLUTICASONE PROPIONATE AND SALMETEROL) POWDER [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 package rows20100908_9e0bdea8-df9b-4873-b24b-919cebff5edd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896212ADVAIR DISKUS 250/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN9e0bdea8-df9b-4873-b24b-919cebff5edd1
896229ADVAIR DISKUS 500/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN9e0bdea8-df9b-4873-b24b-919cebff5edd1
896209fluticasone propionate/salmeterol 250/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN9e0bdea8-df9b-4873-b24b-919cebff5edd1
896228fluticasone propionate/salmeterol 500/50 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSN9e0bdea8-df9b-4873-b24b-919cebff5edd1
89621260 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Advair]SBD9e0bdea8-df9b-4873-b24b-919cebff5edd1
89622960 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Advair]SBD9e0bdea8-df9b-4873-b24b-919cebff5edd1
89620960 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCD9e0bdea8-df9b-4873-b24b-919cebff5edd1
89622860 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder InhalerSCD9e0bdea8-df9b-4873-b24b-919cebff5edd1
896212Advair Diskus 250/50 (fluticasone propionate 250 MCG / salmeterol 50 MCG (as salmeterol xinafoate 72.5 MCG)) per ACTUAT Dry Powder Inhaler, 60 ACTUATSY9e0bdea8-df9b-4873-b24b-919cebff5edd1
896212Advair Diskus 250/50 Dry Powder Inhaler, 60 ACTUATSY9e0bdea8-df9b-4873-b24b-919cebff5edd1
896229Advair Diskus 500/50 (fluticasone propionate 500 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG)) per ACTUAT Dry Powder Inhaler, 60 ACTUATSY9e0bdea8-df9b-4873-b24b-919cebff5edd1
896229Advair Diskus 500/50 Dry Powder Inhaler, 60 ACTUATSY9e0bdea8-df9b-4873-b24b-919cebff5edd1
896209fluticasone propionate 0.25 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUATSY9e0bdea8-df9b-4873-b24b-919cebff5edd1
896228fluticasone propionate 0.5 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUATSY9e0bdea8-df9b-4873-b24b-919cebff5edd1
896209fluticasone propionate 250 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUATSY9e0bdea8-df9b-4873-b24b-919cebff5edd1
896228fluticasone propionate 500 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUATSY9e0bdea8-df9b-4873-b24b-919cebff5edd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-197-012169501970160 in 1 INHALERHistorical