FDA.reportPublic FDA data

Fluticasone Propionate

Product NDC
68788-8762
11-digit product format
687888762
Labeler code
68788
Product ID
68788-8762_b8b3aaf0-be98-4d82-b052-d345740cf2f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone propionate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Preferred Pharmaceuticals Inc.
Application
NDA021433
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-11-11
Substance
FLUTICASONE PROPIONATE
Active strength
44 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluticasone Propionate
Brand name suffix
HFA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE PROPIONATE44 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO2GMZ0LF5W
Rxcui895994

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
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
68788-8762-1Fluticasone PropionateHFA120 in 1 INHALERAEROSOL, METERED1202
68788-8762-1Fluticasone PropionateHFA1 in 1 CARTONAEROSOL, METERED12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8762-1GM - Gram68788-8762d1c9c3db-bbc5-48c7-b65d-a5cadacd2d9912025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8762FLUTICASONE PROPIONATE HFA (FLUTICASONE PROPIONATE) AEROSOL, METERED [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 2 package rows20241113_ff1cf174-ae6f-45f0-a081-26a34e55f9ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895994fluticasone propionate 44 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSNff1cf174-ae6f-45f0-a081-26a34e55f9ea2
895994120 ACTUAT fluticasone propionate 0.044 MG/ACTUAT Metered Dose InhalerSCDff1cf174-ae6f-45f0-a081-26a34e55f9ea2
895994fluticasone propionate 0.044 MG/ACTUAT Metered Dose Inhaler, 120 ACTUATSYff1cf174-ae6f-45f0-a081-26a34e55f9ea2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8762-1687888762011 INHALER in 1 CARTON (68788-8762-1) / 120 AEROSOL, METERED in 1 INHALER1 inhaler2024-11-11NoNoHistorical