FDA.reportPublic FDA data

Topcare Nasal Allergy

Product NDC
36800-621
11-digit product format
368000621
Labeler code
36800
Product ID
36800-621_f9221990-cb52-4305-8833-d805fac324d4
Type
HUMAN OTC DRUG
Nonproprietary name
Triamcinolone acetonide
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Topco Associates LLC
Application
ANDA078104
Marketing category
ANDA
Marketing start
2017-01-25
Substance
TRIAMCINOLONE ACETONIDE
Active strength
55 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 Nasal Allergy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAMCINOLONE ACETONIDE55 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF446C597KA
Rxcui1797913

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d4d7da1a-7fd4-628e-cdae-89e749b1c534Product name720260127
75f7e47b-8736-a182-fc44-22aca8d79689Product name220251211
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2Product name620250516
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-621-01Topcare Nasal Allergy120 in 1 BOTTLE, SPRAYSPRAY, METERED1208
36800-621-01Topcare Nasal Allergy1 in 1 CARTONSPRAY, METERED18
36800-621-02Topcare Nasal Allergy1 in 1 CARTONSPRAY, METERED18
36800-621-02Topcare Nasal Allergy60 in 1 BOTTLE, SPRAYSPRAY, METERED608
36800-621-07Topcare Nasal Allergy1 in 1 CARTONSPRAY, METERED18
36800-621-07Topcare Nasal Allergy144 in 1 BOTTLE, SPRAYSPRAY, METERED1448

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-621TOPCARE NASAL ALLERGY (TRIAMCINOLONE ACETONIDE) SPRAY, METERED [TOPCO ASSOCIATES LLC]8Current NDC, Legacy NDC, 6 package rows20231013_ed8eaf1d-babc-47e1-930b-676ccfbf0de9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797913triamcinolone acetonide 55 MCG/ACTUAT Metered Dose Nasal SprayPSNed8eaf1d-babc-47e1-930b-676ccfbf0de98
1797913triamcinolone acetonide 0.055 MG/ACTUAT Metered Dose Nasal SpraySCDed8eaf1d-babc-47e1-930b-676ccfbf0de98
1797913triamcinolone acetonide 55 MCG/ACTUAT Metered Dose Nasal SpraySYed8eaf1d-babc-47e1-930b-676ccfbf0de98

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-621-01368000621011 BOTTLE, SPRAY in 1 CARTON (36800-621-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY2017-01-250000-00-00NoNoCurrent
36800-621-02368000621021 BOTTLE, SPRAY in 1 CARTON (36800-621-02) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY2020-02-030000-00-00NoNoCurrent
36800-621-07368000621071 BOTTLE, SPRAY in 1 CARTON (36800-621-07) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY2021-02-040000-00-00NoNoCurrent