FDA.reportPublic FDA data

RUGBY FLUTICASONE PROPIONATE NASAL

Product NDC
0536-1183
11-digit product format
005361183
Labeler code
0536
Product ID
0536-1183_8cd709d4-557c-4498-9e63-d5ad3da5c17b
Type
HUMAN OTC DRUG
Nonproprietary name
Fluticasone propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Rugby Laboratories
Application
ANDA207957
Marketing category
ANDA
Marketing start
2018-12-18
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
RUGBY FLUTICASONE PROPIONATE NASAL
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
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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1183-13RUGBY FLUTICASONE PROPIONATE NASAL72 in 1 BOTTLE, SPRAYSPRAY, METERED726
0536-1183-13RUGBY FLUTICASONE PROPIONATE NASAL1 in 1 CARTONSPRAY, METERED16
0536-1183-21RUGBY FLUTICASONE PROPIONATE NASAL1 in 1 CARTONSPRAY, METERED16
0536-1183-21RUGBY FLUTICASONE PROPIONATE NASAL144 in 1 BOTTLE, SPRAYSPRAY, METERED1446
0536-1183-65RUGBY FLUTICASONE PROPIONATE NASAL1 in 1 CARTONSPRAY, METERED16
0536-1183-65RUGBY FLUTICASONE PROPIONATE NASAL120 in 1 BOTTLE, SPRAYSPRAY, METERED1206
0536-1183-99RUGBY FLUTICASONE PROPIONATE NASAL60 in 1 BOTTLE, SPRAYSPRAY, METERED606
0536-1183-99RUGBY FLUTICASONE PROPIONATE NASAL1 in 1 CARTONSPRAY, METERED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1183-13ML - Milliliter0536-11834a194433-a0fc-4f26-ba06-2a460ecbe5b512024-11-05
0536-1183-21ML - Milliliter0536-118314007ab3-ac8f-48d7-8a78-6206ed3be06912024-11-05
0536-1183-65ML - Milliliter0536-1183acea4b1d-eb23-4b5f-9944-f1040f765d5212019-05-02
0536-1183-99ML - Milliliter0536-1183ae3deb2c-bb9a-4f2d-8e96-bf4b5318852012019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1183RUGBY FLUTICASONE PROPIONATE NASAL (FLUTICASONE PROPIONATE) SPRAY, METERED [RUGBY LABORATORIES]5Current NDC, Legacy NDC, 8 package rows20240806_5227df05-f2c2-4bc4-91ee-da0fd03d1095.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN5227df05-f2c2-4bc4-91ee-da0fd03d10956
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD5227df05-f2c2-4bc4-91ee-da0fd03d10956
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY5227df05-f2c2-4bc4-91ee-da0fd03d10956
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN0c4eb6cb-abc9-4945-8f30-cfa8b9eb579c5
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD0c4eb6cb-abc9-4945-8f30-cfa8b9eb579c5
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY0c4eb6cb-abc9-4945-8f30-cfa8b9eb579c5
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN95765842-415e-438b-8105-f6d93cddbdd01
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNe38d8796-b08c-49a8-94b8-0c2fdeb52a811
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD95765842-415e-438b-8105-f6d93cddbdd01
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDe38d8796-b08c-49a8-94b8-0c2fdeb52a811
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY95765842-415e-438b-8105-f6d93cddbdd01
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySYe38d8796-b08c-49a8-94b8-0c2fdeb52a811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0536-1183-13005361183131 BOTTLE, SPRAY in 1 CARTON (0536-1183-13) / 72 SPRAY, METERED in 1 BOTTLE, SPRAY2024-08-05NoNoHistorical
0536-1183-21005361183211 BOTTLE, SPRAY in 1 CARTON (0536-1183-21) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY2024-08-05NoNoHistorical
0536-1183-65005361183651 BOTTLE, SPRAY in 1 CARTON (0536-1183-65) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY2018-12-180000-00-00NoNoCurrent
0536-1183-99005361183991 BOTTLE, SPRAY in 1 CARTON (0536-1183-99) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY2018-12-180000-00-00NoNoCurrent