FDA.reportPublic FDA data

Mometasone Furoate

Product NDC
68788-8357
11-digit product format
687888357
Labeler code
68788
Product ID
68788-8357_1303c412-96c3-4a10-8f5a-0ce6bf23919c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone Furoate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA076067
Marketing category
ANDA
Marketing start
2023-02-10
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
68788-8357-4Mometasone Furoate1 in 1 CARTONOINTMENT13
68788-8357-4Mometasone Furoate45 g in 1 TUBEOINTMENT453

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8357-4GM - Gram68788-8357f47e35ac-4c9a-4f98-95a8-94f77f103cf312023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8357MOMETASONE FUROATE OINTMENT [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 2 package rows20240724_bfe3d098-a5f8-4e5d-9fa6-eac167bad3e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151029mometasone furoate 0.1 % Topical OintmentPSNbfe3d098-a5f8-4e5d-9fa6-eac167bad3e93
151029mometasone furoate 0.001 MG/MG Topical OintmentSCDbfe3d098-a5f8-4e5d-9fa6-eac167bad3e93
151029mometasone furoate 0.1 % Topical OintmentSYbfe3d098-a5f8-4e5d-9fa6-eac167bad3e93
151029mometasone furoate 1 MG/GM Topical OintmentSYbfe3d098-a5f8-4e5d-9fa6-eac167bad3e93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8357-4687888357041 TUBE in 1 CARTON (68788-8357-4) / 45 g in 1 TUBE1 tube2023-02-10NoNoHistorical