FDA.reportPublic FDA data

Fluticasone Propionate

Product NDC
66993-078
11-digit product format
669930078
Labeler code
66993
Product ID
66993-078_364e717b-7aee-47a8-a358-72e6aaa43e1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone propionate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Prasco Laboratories
Application
NDA021433
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2022-05-23
Substance
FLUTICASONE PROPIONATE
Active strength
44 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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
Brand name suffix
HFA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE PROPIONATE44 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO2GMZ0LF5W
Rxcui895994, 895999, 896004

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
66993-078-96Fluticasone PropionateHFA120 in 1 INHALERAEROSOL, METERED1205
66993-078-96Fluticasone PropionateHFA1 in 1 CARTONAEROSOL, METERED15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-078-96GM - Gram66993-0783422b2fe-967d-4589-bcda-33720db450e812022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-078FLUTICASONE PROPIONATE HFA (FLUTICASONE PROPIONATE) AEROSOL, METERED [PRASCO LABORATORIES]4Current NDC, Legacy NDC, 2 package rows20240915_99249b31-bf0a-464f-8335-845279350dbe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895999fluticasone propionate 110 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSN99249b31-bf0a-464f-8335-845279350dbe5
896004fluticasone propionate 220 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSN99249b31-bf0a-464f-8335-845279350dbe5
895994fluticasone propionate 44 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSN99249b31-bf0a-464f-8335-845279350dbe5
895994120 ACTUAT fluticasone propionate 0.044 MG/ACTUAT Metered Dose InhalerSCD99249b31-bf0a-464f-8335-845279350dbe5
895999120 ACTUAT fluticasone propionate 0.11 MG/ACTUAT Metered Dose InhalerSCD99249b31-bf0a-464f-8335-845279350dbe5
896004120 ACTUAT fluticasone propionate 0.22 MG/ACTUAT Metered Dose InhalerSCD99249b31-bf0a-464f-8335-845279350dbe5
895994fluticasone propionate 0.044 MG/ACTUAT Metered Dose Inhaler, 120 ACTUATSY99249b31-bf0a-464f-8335-845279350dbe5
895999fluticasone propionate 0.11 MG/ACTUAT Metered Dose Inhaler, 120 ACTUATSY99249b31-bf0a-464f-8335-845279350dbe5
896004fluticasone propionate 0.22 MG/ACTUAT Metered Dose Inhaler, 120 ACTUATSY99249b31-bf0a-464f-8335-845279350dbe5
896004fluticasone propionate 220 MCG/ACTUAT Metered Dose Inhaler, 120 ACTUATSY99249b31-bf0a-464f-8335-845279350dbe5
895994fluticasone propionate 44 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSN674b1c81-359d-4fc4-8ce6-a53931b171e03
895994120 ACTUAT fluticasone propionate 0.044 MG/ACTUAT Metered Dose InhalerSCD674b1c81-359d-4fc4-8ce6-a53931b171e03
895994fluticasone propionate 0.044 MG/ACTUAT Metered Dose Inhaler, 120 ACTUATSY674b1c81-359d-4fc4-8ce6-a53931b171e03
895994fluticasone propionate 44 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSNbc0b998d-e13a-4d95-89ac-61782dc905c92
895994fluticasone propionate 44 MCG/INHAL Metered Dose Inhaler, 120 ActuationsPSNff1cf174-ae6f-45f0-a081-26a34e55f9ea2
895994120 ACTUAT fluticasone propionate 0.044 MG/ACTUAT Metered Dose InhalerSCDbc0b998d-e13a-4d95-89ac-61782dc905c92
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 ACTUATSYbc0b998d-e13a-4d95-89ac-61782dc905c92
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 startMarketing endSampleExclude flagStatus
66993-078-96669930078961 INHALER in 1 CARTON (66993-078-96) / 120 AEROSOL, METERED in 1 INHALER1 inhaler2022-05-230000-00-00NoNoCurrent