Fluticasone Propionate and Salmeterol

Product NDC
70518-4347
11-digit product format
705184347
Labeler code
70518
Product ID
70518-4347_3ba1895a-2996-f42b-e063-6394a90a842b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone propionate and salmeterol
Dosage form
POWDER
Route
RESPIRATORY (INHALATION)
Labeler
REMEDYREPACK INC.
Application
NDA021077
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2025-05-29
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
O2GMZ0LF5WFLUTICASONE PROPIONATE80474-14-2FLUTICASONE PROPIONATE
6EW8Q962A5SALMETEROL XINAFOATE94749-08-3SALMETEROL XINAFOATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4347-0705184347001 INHALER in 1 CARTON (70518-4347-0) / 60 POWDER in 1 INHALER1 inhaler2025-05-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Fluticasone Propionate and Salmeterol DISKUS - REMEDYREPACK INC.REMEDYREPACK INC.2025-08-05HUMAN PRESCRIPTION DRUG LABEL2