topcare fluticasone propionate nasal

Product NDC
36800-222
11-digit product format
368000222
Labeler code
36800
Product ID
36800-222_343d4087-6c6d-430a-a927-d1c0cedf420e
Type
HUMAN OTC DRUG
Nonproprietary name
Fluticasone propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Topco Associates LLC
Application
ANDA207957
Marketing category
ANDA
Marketing start
2016-06-24
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
topcare fluticasone propionate nasal
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
36800-222-01topcare fluticasone propionate nasal1 in 1 CARTONSPRAY, METERED15
36800-222-01topcare fluticasone propionate nasal120 in 1 BOTTLESPRAY, METERED1205
36800-222-03topcare fluticasone propionate nasal2 in 1 CARTONSPRAY, METERED25
36800-222-03topcare fluticasone propionate nasal120 in 1 BOTTLESPRAY, METERED1205
36800-222-09topcare fluticasone propionate nasal1 in 1 CARTONSPRAY, METERED15
36800-222-09topcare fluticasone propionate nasal144 in 1 BOTTLESPRAY, METERED1445
36800-222-10topcare fluticasone propionate nasal144 in 1 BOTTLESPRAY, METERED1445
36800-222-10topcare fluticasone propionate nasal2 in 1 CARTONSPRAY, METERED25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-222-01ML - Milliliter36800-222ea260d54-06fd-4f9f-aeb3-80e7f91d2b7d12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-222TOPCARE FLUTICASONE PROPIONATE NASAL (FLUTICASONE PROPIONATE) SPRAY, METERED [TOPCO ASSOCIATES LLC]5Current NDC, Legacy NDC, 8 package rows20221102_f7c425d2-4afb-478f-83bc-eb336910233b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNf7c425d2-4afb-478f-83bc-eb336910233b5
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDf7c425d2-4afb-478f-83bc-eb336910233b5
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySYf7c425d2-4afb-478f-83bc-eb336910233b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-222-01368000222011 BOTTLE in 1 CARTON (36800-222-01) / 120 SPRAY, METERED in 1 BOTTLE1 bottle2016-06-240000-00-00NoNoCurrent
36800-222-03368000222032 BOTTLE in 1 CARTON (36800-222-03) / 120 SPRAY, METERED in 1 BOTTLE2 bottle2017-10-190000-00-00NoNoCurrent
36800-222-09368000222091 BOTTLE in 1 CARTON (36800-222-09) / 144 SPRAY, METERED in 1 BOTTLE1 bottle2021-05-260000-00-00NoNoCurrent
36800-222-10368000222102 BOTTLE in 1 CARTON (36800-222-10) / 144 SPRAY, METERED in 1 BOTTLE2 bottle2021-05-260000-00-00NoNoCurrent