FDA.reportPublic FDA data

Mometasone Furoate

Product NDC
51672-1311
11-digit product format
516721311
Labeler code
51672
Product ID
51672-1311_39619c2c-5804-85d9-e063-6294a90aa109
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone Furoate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA076624
Marketing category
ANDA
Marketing start
2004-12-03
Substance
MOMETASONE FUROATE
Active strength
1 mg/g
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/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04201GDN4R
Rxcui151029

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
51672-1311-1Mometasone Furoate15 g in 1 TUBEOINTMENT155
51672-1311-1Mometasone Furoate1 in 1 CARTONOINTMENT15
51672-1311-6Mometasone Furoate1 in 1 CARTONOINTMENT15
51672-1311-6Mometasone Furoate45 g in 1 TUBEOINTMENT455

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Mometasone FuroateACTIVE INGREDIENT04201GDN4RMOMETASONE FUROATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
MometasoneACTIVE MOIETY8HR4QJ6DW8MOMETASONE FUROATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
hexylene glycolINACTIVE INGREDIENTKEH0A3F75JMOMETASONE FUROATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
petrolatumINACTIVE INGREDIENT4T6H12BN9UMOMETASONE FUROATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene glycol stearateINACTIVE INGREDIENTMZM1I680W0MOMETASONE FUROATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
white waxINACTIVE INGREDIENT7G1J5DA97FMOMETASONE FUROATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1311MOMETASONE FUROATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4Current NDC, Legacy NDC, 4 package rows20181010_d8cf50d4-0448-4527-a498-cddd511213f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151029mometasone furoate 0.1 % Topical OintmentPSNd8cf50d4-0448-4527-a498-cddd511213f05
151029mometasone furoate 0.001 MG/MG Topical OintmentSCDd8cf50d4-0448-4527-a498-cddd511213f05
151029mometasone furoate 0.1 % Topical OintmentSYd8cf50d4-0448-4527-a498-cddd511213f05
151029mometasone furoate 1 MG/GM Topical OintmentSYd8cf50d4-0448-4527-a498-cddd511213f05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1311-1516721311011 TUBE in 1 CARTON (51672-1311-1) / 15 g in 1 TUBE1 tube2004-12-030000-00-00NoNoCurrent
51672-1311-6516721311061 TUBE in 1 CARTON (51672-1311-6) / 45 g in 1 TUBE1 tube2004-12-030000-00-00NoNoCurrent