FLUTICASONE

Product NDC
61919-004
11-digit product format
619190004
Labeler code
61919
Product ID
61919-004_861d65c9-fb38-b548-e053-2a91aa0a2366
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUTICASONE
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Direct RX
Application
ANDA078492
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
FLUTICASONE PROPIONATE
Active strength
50 ug/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
61919-004-162025-01-31C16284748780-11030e365-3da8-111a-e063-dadaa90a10e2FLUTICASONE PROPIONATE SPRAY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-004-16FLUTICASONE1 in 1 BOXSPRAY, METERED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-004-16GM - Gram61919-004e997862d-cff2-4dab-83b7-f69af6bf298d12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5WFLUTICASONE SPRAY, METERED [DIRECT RX]1
FLUTICASONEACTIVE MOIETYCUT2W21N7UFLUTICASONE SPRAY, METERED [DIRECT RX]1
Anhydrous DextroseINACTIVE INGREDIENT5SL0G7R0OKFLUTICASONE SPRAY, METERED [DIRECT RX]1
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7FLUTICASONE SPRAY, METERED [DIRECT RX]1
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311FLUTICASONE SPRAY, METERED [DIRECT RX]1
Phenylethyl AlcoholINACTIVE INGREDIENTML9LGA7468FLUTICASONE SPRAY, METERED [DIRECT RX]1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HFLUTICASONE SPRAY, METERED [DIRECT RX]1
WaterINACTIVE INGREDIENT059QF0KO0RFLUTICASONE SPRAY, METERED [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-004FLUTICASONE SPRAY, METERED [DIRECT RX]4Legacy NDC, 1 package rows20190410_ab7529ac-fa19-4be8-9906-8889fa3e8398.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNab7529ac-fa19-4be8-9906-8889fa3e83984
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDab7529ac-fa19-4be8-9906-8889fa3e83984
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySYab7529ac-fa19-4be8-9906-8889fa3e83984

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-004-16619190004161 SPRAY, METERED in 1 BOX (61919-004-16) 2014-12-100000-00-00NoNoCurrent