FDA.reportPublic FDA data

Mometasone Furoate

Product NDC
63629-8685
11-digit product format
636298685
Labeler code
63629
Product ID
63629-8685_8a2a552e-8cc7-4a5b-9921-ab917a040962
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone Furoate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA077180
Marketing category
ANDA
Marketing start
2008-12-11
Substance
MOMETASONE FUROATE
Active strength
1 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], 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
Mometasone Furoate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOMETASONE FUROATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04201GDN4R
Rxcui151030

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
63629-8685-1Mometasone Furoate1 in 1 CARTONSOLUTION1105
63629-8685-1Mometasone Furoate30 mL in 1 BOTTLESOLUTION30105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8685-1ML - Milliliter63629-86851bd18968-384f-4b03-957e-02d4679a1b0512023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8685MOMETASONE FUROATE SOLUTION [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 2 package rows20240814_5f1f2136-9e10-4d43-bb35-ed285c744fe4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151030mometasone furoate 0.1 % Topical Solution (Lotion)PSN5f1f2136-9e10-4d43-bb35-ed285c744fe4105
151030mometasone furoate 1 MG/ML Topical LotionSCD5f1f2136-9e10-4d43-bb35-ed285c744fe4105
151030mometasone furoate 0.1 % Topical LotionSY5f1f2136-9e10-4d43-bb35-ed285c744fe4105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8685-1636298685011 BOTTLE in 1 CARTON (63629-8685-1) / 30 mL in 1 BOTTLE1 bottle2009-02-020000-00-00NoNoCurrent