FDA.reportPublic FDA data

Fluticasone Propionate and Salmeterol

Product NDC
63629-8811
11-digit product format
636298811
Labeler code
63629
Product ID
63629-8811_b6d73632-205b-4d93-bc38-f520fd6c189b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluticasone Propionate and Salmeterol
Dosage form
POWDER, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Bryant Ranch Prepack
Application
NDA208799
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2017-04-28
Substance
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Active strength
55; 14 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
Fluticasone Propionate and Salmeterol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE PROPIONATE55 ug/1
SALMETEROL XINAFOATE14 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO2GMZ0LF5W, 6EW8Q962A5
Rxcui1918209

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
63629-8811-1Fluticasone Propionate and Salmeterol1 in 1 POUCHPOWDER, METERED1105
63629-8811-1Fluticasone Propionate and Salmeterol1 in 1 CARTONPOWDER, METERED1105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8811-1EA - Each63629-881189d0a0bf-f306-45c9-8040-1a3398cecaf812021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8811FLUTICASONE PROPIONATE AND SALMETEROL POWDER, METERED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 2 package rows20240504_038db4da-1448-4603-a34d-2efd9059811b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1918209fluticasone propionate/salmeterol 55/14 MCG/INHAL Dry Powder Inhaler, 60 ActuationsPSN038db4da-1448-4603-a34d-2efd9059811b105
191820960 ACTUAT fluticasone propionate 0.055 MG/ACTUAT / salmeterol 0.014 MG/ACTUAT Dry Powder InhalerSCD038db4da-1448-4603-a34d-2efd9059811b105
1918209fluticasone propionate 55 MCG/ACTUAT / salmeterol xinafoate 14 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUATSSY038db4da-1448-4603-a34d-2efd9059811b105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8811-1636298811011 POUCH in 1 CARTON (63629-8811-1) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER1 pouch2017-04-280000-00-00NoNoCurrent