FDA.reportPublic FDA data

allergy nasal

Product NDC
0363-2060
11-digit product format
003632060
Labeler code
0363
Product ID
0363-2060_f7a19843-7bd4-4ab4-ad89-11bd951342db
Type
HUMAN OTC DRUG
Nonproprietary name
mometasone furoate monohydrate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Walgreen Company
Application
NDA215712
Marketing category
NDA
Marketing start
2023-03-30
Substance
MOMETASONE FUROATE MONOHYDRATE
Active strength
50 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], 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
MOMETASONE FUROATE MONOHYDRATE50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMTW0WEG809
Rxcui1797865

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
624001e0-0eba-4aac-a60c-c2ecb37d4f08Product name120220927
1cbe9071-502b-482d-9c24-839b43446576Product name120200123
ce567bde-218c-2386-f79b-42addb0c34fbProduct name220180829
1e8b10fc-5c6a-4af6-9363-4bda9402a4f4Product name120180209
fa8c1c3a-f36c-46b1-b4f1-4e877f3dcb1dProduct name220170613
511188c3-b8c1-4966-aa31-5463cfd4fa48Product name120141222
6dcdf27c-6d6a-2465-ccae-faeb308e8070Product name120140508
aca60174-7f12-2753-ec74-0eb827cf0776Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-2060-02allergy nasal120 in 1 BOTTLE, SPRAYSPRAY, METERED1205
0363-2060-02allergy nasal1 in 1 PACKAGESPRAY, METERED15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-2060-02ML - Milliliter0363-2060d153b45f-3227-4f0d-ace3-b9da8c3bb03c12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-2060ALLERGY NASAL (MOMETASONE FUROATE MONOHYDRATE) SPRAY, METERED [WALGREEN COMPANY]3Current NDC, 2 package rows20240906_9f28b399-0035-4753-8d1b-ddea212f86e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797865mometasone furoate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN9f28b399-0035-4753-8d1b-ddea212f86e85
1797865mometasone furoate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD9f28b399-0035-4753-8d1b-ddea212f86e85
1797865mometasone furoate 50 MCG/ACTUAT Metered Dose Nasal SpraySY9f28b399-0035-4753-8d1b-ddea212f86e85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0363-2060-02003632060021 BOTTLE, SPRAY in 1 PACKAGE (0363-2060-02) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY2023-03-30NoNoHistorical