Equaline Fluticasone Propionate

Product NDC
41163-023
11-digit product format
411630023
Labeler code
41163
Product ID
41163-023_5aedaece-fcb5-47f7-83c3-2658d46538e5
Type
HUMAN OTC DRUG
Nonproprietary name
Fluticasone propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
ANDA207957
Marketing category
ANDA
Marketing start
2016-05-31
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
Equaline 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-023-01Equaline Fluticasone Propionate120 in 1 BOTTLE, SPRAYSPRAY, METERED1208
41163-023-01Equaline Fluticasone Propionate1 in 1 CARTONSPRAY, METERED18
41163-023-02Equaline Fluticasone Propionate1 in 1 CARTONSPRAY, METERED18
41163-023-02Equaline Fluticasone Propionate60 in 1 BOTTLE, SPRAYSPRAY, METERED608
41163-023-08Equaline Fluticasone Propionate72 in 1 BOTTLE, SPRAYSPRAY, METERED728
41163-023-08Equaline Fluticasone Propionate1 in 1 CARTONSPRAY, METERED18
41163-023-09Equaline Fluticasone Propionate144 in 1 BOTTLE, SPRAYSPRAY, METERED1448
41163-023-09Equaline Fluticasone Propionate1 in 1 CARTONSPRAY, METERED18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-023-01ML - Milliliter41163-02339e88239-0e9e-433b-9aca-998f35a6eb3712016-07-19
41163-023-02ML - Milliliter41163-0235727e311-133e-4a34-a673-d14e890b83aa12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-023EQUALINE FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) SPRAY, METERED [UNITED NATURAL FOODS, INC. DBA UNFI]6Current NDC, Legacy NDC, 8 package rows20231003_dbaa5264-bbc9-411c-89bb-4aef3ee96459.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNdbaa5264-bbc9-411c-89bb-4aef3ee964598
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDdbaa5264-bbc9-411c-89bb-4aef3ee964598
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySYdbaa5264-bbc9-411c-89bb-4aef3ee964598

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-023-01411630023011 BOTTLE in 1 CARTON (41163-023-01) > 120 SPRAY, METERED in 1 BOTTLE1 bottle2016-05-310000-00-00NoNoCurrent
41163-023-02411630023021 BOTTLE in 1 CARTON (41163-023-02) > 60 SPRAY, METERED in 1 BOTTLE1 bottle2016-07-030000-00-00NoNoCurrent
41163-023-08411630023081 BOTTLE, SPRAY in 1 CARTON (41163-023-08) / 72 SPRAY, METERED in 1 BOTTLE, SPRAY2021-03-180000-00-00NoNoCurrent
41163-023-09411630023091 BOTTLE, SPRAY in 1 CARTON (41163-023-09) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY2021-03-180000-00-00NoNoCurrent