FDA.reportPublic FDA data

Fluticasone Propionate spray, metered

Product NDC
62135-810
11-digit product format
621350810
Labeler code
62135
Product ID
62135-810_4d793a34-187e-05ba-e063-6394a90a69b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Chartwell RX, LLC
Application
ANDA078492
Marketing category
ANDA
Marketing start
2012-01-09
Substance
FLUTICASONE PROPIONATE
Active strength
50 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 spray, metered
Listing expiration
2027-12-31

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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
a31ad3df-8021-2ea1-94eb-0fe2f49b7729Product name420220719
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
813fe018-3e3c-40e4-8f71-7ab50f3dfe81Product name220180723
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
3bcd721e-0555-4bc3-96c6-690471ff9d94Product name120171113
9f9452df-fa34-43d4-97fe-c6605344c5a8Product name120171113
0e5a25a6-9f05-44b5-8449-aa63e59f7202Product name120170426
f3c5232f-03de-44f5-996a-90cd9c08bc60Product name120170426
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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
62135-810-612025-07-29C16284748780-13b156c62-3148-fb37-e063-e6dba90a4e07Fluticasone Propionate Nasal Spray, USP These 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
62135-810-612025-07-29C16284748780-13b156c62-3148-fb37-e063-e6dba90a4e07Fluticasone Propionate Nasal Spray, USP These 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
62135-810-612025-07-29C16284748780-13b156c62-3148-fb37-e063-e6dba90a4e07FLUTICASONE PROPIONATE nasal spray These 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
62135-810-61Fluticasone Propionate spray, metered120 in 1 BOTTLE, SPRAYSPRAY, METERED1204
62135-810-61Fluticasone Propionate spray, metered1 in 1 CARTONSPRAY, METERED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-810-61GM - Gram62135-81020346b54-77c8-4945-8a8c-0dbdc59ec4df12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-810FLUTICASONE PROPIONATE SPRAY, METERED (FLUTICASONE PROPIONATE) SPRAY, METERED [CHARTWELL RX, LLC]2Current NDC, 2 package rows20241030_71a2609f-c4b9-49b0-8185-83c20c22e1d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN71a2609f-c4b9-49b0-8185-83c20c22e1d64
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD71a2609f-c4b9-49b0-8185-83c20c22e1d64
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY71a2609f-c4b9-49b0-8185-83c20c22e1d64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62135-810-61621350810611 BOTTLE, SPRAY in 1 CARTON (62135-810-61) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY2023-12-08NoNoCurrent