FDA.reportPublic FDA data

Fluticasone Propionate

Product NDC
68071-4868
11-digit product format
680714868
Labeler code
68071
Product ID
68071-4868_1ae1a5f4-841b-25d8-e063-6294a90a35c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA076504
Marketing category
ANDA
Marketing start
2006-02-22
Substance
FLUTICASONE PROPIONATE
Active strength
50 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
Listing expiration
2026-12-31

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
68071-4868-52023-05-31C16284748780-1ba0f9c33-3b5b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FLUTICASONE PROPIONATE NASAL SPRAY safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE NASAL SPRAY. FLUTICASONE PROPIONATE nasal spray Initial U.S. Approval: 1994
68071-4868-52023-01-30C16284748780-1ba0f9c33-3b5b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FLUTICASONE PROPIONATE NASAL SPRAY safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE NASAL SPRAY. FLUTICASONE PROPIONATE nasal spray Initial U.S. Approval: 1994
68071-4868-52021-02-17C16284748780-1ba0f9c33-3b5b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FLUTICASONE PROPIONATE NASAL SPRAY safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE NASAL SPRAY. FLUTICASONE PROPIONATE nasal spray Initial U.S. Approval: 1994
68071-4868-52021-01-29C16284748780-1ba0f9c33-3b5b-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FLUTICASONE PROPIONATE NASAL SPRAY safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE NASAL SPRAY. FLUTICASONE PROPIONATE nasal spray Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4868-5Fluticasone Propionate120 in 1 BOTTLE, GLASSSPRAY, METERED1204
68071-4868-5Fluticasone Propionate1 in 1 CARTONSPRAY, METERED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4868FLUTICASONE PROPIONATE SPRAY, METERED [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 2 package rows20240616_8761a5e1-a9cb-0622-e053-2a95a90a3504.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN8761a5e1-a9cb-0622-e053-2a95a90a35044
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD8761a5e1-a9cb-0622-e053-2a95a90a35044
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY8761a5e1-a9cb-0622-e053-2a95a90a35044

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4868-5680714868051 BOTTLE, GLASS in 1 CARTON (68071-4868-5) / 120 SPRAY, METERED in 1 BOTTLE, GLASS2023-05-260000-00-00NoNoCurrent