FDA.reportPublic FDA data

Fluticasone Propionate

Product NDC
55700-714
11-digit product format
557000714
Labeler code
55700
Product ID
55700-714_b0e3bf0c-f3ac-4c01-a4eb-67d87adf389e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Quality Care Products, LLC
Application
ANDA077538
Marketing category
ANDA
Marketing start
2019-01-04
Marketing end
2027-07-31
Substance
FLUTICASONE PROPIONATE
Active strength
50 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluticasone Propionate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE PROPIONATE50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO2GMZ0LF5W
Rxcui1797907

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-714-162023-10-17C16284748780-1f386c649-c713-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FLUTICASONE propionate safely and effectively. See full prescribing information for FLUTICASONE propionate. FLUTICASONE propionate nasal spray, USP, 50 mcg FOR INTRANASAL USE Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55700-714-16Fluticasone Propionate1 in 1 CARTONSPRAY, METERED15
55700-714-16Fluticasone Propionate120 in 1 BOTTLE, SPRAYSPRAY, METERED1205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-714-16GM - Gram55700-7145c35a8a3-6e07-4b1f-9078-6eddb829f07612019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-714FLUTICASONE PROPIONATE SPRAY, METERED [QUALITY CARE PRODUCTS, LLC]5Current NDC, Legacy NDC, 2 package rows20241220_1bcf25b7-25bc-489e-b5b6-3ae2b3babf6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN1bcf25b7-25bc-489e-b5b6-3ae2b3babf6e5
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD1bcf25b7-25bc-489e-b5b6-3ae2b3babf6e5
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY1bcf25b7-25bc-489e-b5b6-3ae2b3babf6e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-714-16557000714161 BOTTLE, SPRAY in 1 CARTON (55700-714-16) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY2019-01-042027-07-31NoNoCurrent