FDA.reportPublic FDA data

MOMETASONE FUROATE

Product NDC
21922-072
11-digit product format
219220072
Labeler code
21922
Product ID
21922-072_c336602d-2291-4ab2-97b2-8390f2f5270d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MOMETASONE FUROATE
Dosage form
LOTION
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
ANDA076499
Marketing category
ANDA
Marketing start
2025-01-22
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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
6dcdf27c-6d6a-2465-ccae-faeb308e8070Product name120140508
aca60174-7f12-2753-ec74-0eb827cf0776Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21922-072-01MOMETASONE FUROATE60 mL in 1 BOTTLELOTION602
21922-072-01MOMETASONE FUROATE1 in 1 BOTTLELOTION12
21922-072-21MOMETASONE FUROATE30 mL in 1 BOTTLELOTION302
21922-072-21MOMETASONE FUROATE1 in 1 CARTONLOTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-072-01ML - Milliliter21922-072435b6b14-a236-4156-b29f-ab4e4c3595d812025-05-14
21922-072-21ML - Milliliter21922-072173cd049-bc7f-4493-9443-c06fe00d0a4912025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-072MOMETASONE FUROATE LOTION [ENCUBE ETHICALS PRIVATE LIMITED]1Current NDC, 4 package rows20250123_1ebaac16-432e-4e92-9d58-718bd76ae368.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151030mometasone furoate 0.1 % Topical Solution (Lotion)PSN1ebaac16-432e-4e92-9d58-718bd76ae3682
151030mometasone furoate 1 MG/ML Topical LotionSCD1ebaac16-432e-4e92-9d58-718bd76ae3682
151030mometasone furoate 0.1 % Topical LotionSY1ebaac16-432e-4e92-9d58-718bd76ae3682

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21922-072-01219220072011 BOTTLE in 1 BOTTLE (21922-072-01) / 60 mL in 1 BOTTLE1 bottle2025-01-22NoNoCurrent
21922-072-21219220072211 BOTTLE in 1 CARTON (21922-072-21) / 30 mL in 1 BOTTLE1 bottle2025-01-22NoNoCurrent