FDA.reportPublic FDA data

Allergy Nasal

Product NDC
0363-0811
11-digit product format
003630811
Labeler code
0363
Product ID
0363-0811_8ea8066c-1cdc-49f7-a99a-a432e82293ef
Type
HUMAN OTC DRUG
Nonproprietary name
Triamcinolone acetonide
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Walgreen Company
Application
ANDA078104
Marketing category
ANDA
Marketing start
2016-04-10
Substance
TRIAMCINOLONE ACETONIDE
Active strength
55 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
Allergy Nasal
Listing expiration
2027-12-31

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
0363-0811-01Allergy Nasal1 in 1 CARTONSPRAY, METERED19
0363-0811-01Allergy Nasal120 in 1 BOTTLESPRAY, METERED1209
0363-0811-02Allergy Nasal1 in 1 CARTONSPRAY, METERED19
0363-0811-02Allergy Nasal60 in 1 BOTTLESPRAY, METERED609
0363-0811-03Allergy Nasal2 in 1 CARTONSPRAY, METERED29
0363-0811-03Allergy Nasal120 in 1 BOTTLESPRAY, METERED1209
0363-0811-07Allergy Nasal1 in 1 CARTONSPRAY, METERED19
0363-0811-07Allergy Nasal144 in 1 BOTTLESPRAY, METERED1449

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0811-01ML - Milliliter0363-08117a192471-5bc3-4251-a895-37dba0f45b1812019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0811ALLERGY NASAL (TRIAMCINOLONE ACETONIDE) SPRAY, METERED [WALGREEN COMPANY]8Current NDC, Legacy NDC, 8 package rows20241127_a33aa2f3-9e9e-4408-b671-508c79a29c06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797913triamcinolone acetonide 55 MCG/ACTUAT Metered Dose Nasal SprayPSNa33aa2f3-9e9e-4408-b671-508c79a29c069
1797913triamcinolone acetonide 0.055 MG/ACTUAT Metered Dose Nasal SpraySCDa33aa2f3-9e9e-4408-b671-508c79a29c069
1797913triamcinolone acetonide 55 MCG/ACTUAT Metered Dose Nasal SpraySYa33aa2f3-9e9e-4408-b671-508c79a29c069

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0811-01003630811011 BOTTLE in 1 CARTON (0363-0811-01) / 120 SPRAY, METERED in 1 BOTTLE1 bottle2016-04-100000-00-00NoNoCurrent
0363-0811-02003630811021 BOTTLE in 1 CARTON (0363-0811-02) / 60 SPRAY, METERED in 1 BOTTLE1 bottle2017-08-020000-00-00NoNoCurrent
0363-0811-03003630811032 BOTTLE in 1 CARTON (0363-0811-03) / 120 SPRAY, METERED in 1 BOTTLE2 bottle2016-11-030000-00-00NoNoCurrent
0363-0811-07003630811071 BOTTLE in 1 CARTON (0363-0811-07) > 144 SPRAY, METERED in 1 BOTTLE1 bottle2021-03-090000-00-00NoNoCurrent