FDA.reportPublic FDA data

Mometasone Furoate

Product NDC
72162-1392
11-digit product format
721621392
Labeler code
72162
Product ID
72162-1392_539d6967-2a14-4c0c-b33d-36fb90682830
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
72162-1392-3Mometasone Furoate1 in 1 CARTONSOLUTION1100
72162-1392-3Mometasone Furoate30 mL in 1 BOTTLESOLUTION30100
72162-1392-6Mometasone Furoate1 in 1 CARTONSOLUTION1100
72162-1392-6Mometasone Furoate60 mL in 1 BOTTLESOLUTION60100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1392-3ML - Milliliter72162-139282fdeb7c-9af8-4a9d-85fb-81f22ee1e4a412023-09-05
72162-1392-6ML - Milliliter72162-139280c4cf81-367a-4d5e-8968-dd1ee39cf34512023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1392MOMETASONE FUROATE SOLUTION [BRYANT RANCH PREPACK]100Current NDC, 4 package rows20230823_d15edb8b-c8b2-4023-992e-f79cefa2d1e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151030mometasone furoate 0.1 % Topical Solution (Lotion)PSNd15edb8b-c8b2-4023-992e-f79cefa2d1e8100
151030mometasone furoate 1 MG/ML Topical LotionSCDd15edb8b-c8b2-4023-992e-f79cefa2d1e8100
151030mometasone furoate 0.1 % Topical LotionSYd15edb8b-c8b2-4023-992e-f79cefa2d1e8100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1392-3721621392031 BOTTLE in 1 CARTON (72162-1392-3) / 30 mL in 1 BOTTLE1 bottle2023-08-16NoNoCurrent
72162-1392-6721621392061 BOTTLE in 1 CARTON (72162-1392-6) / 60 mL in 1 BOTTLE1 bottle2023-08-16NoNoCurrent