FDA.reportPublic FDA data

Mometasone Furoate

Product NDC
13668-527
11-digit product format
136680527
Labeler code
13668
Product ID
13668-527_4ea0ace8-3f86-42c2-9242-7eef56d15174
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone Furoate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA207899
Marketing category
ANDA
Marketing start
2024-12-15
Substance
MOMETASONE FUROATE
Active strength
1 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mometasone Furoate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOMETASONE FUROATE1 mg/1

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
13668-527-01Mometasone Furoate15 in 1 BOXOINTMENT158
13668-527-04Mometasone Furoate45 in 1 BOXOINTMENT458

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-527-01GM - Gram13668-5276ce1cf91-5e98-4258-b4ba-b0694835410b12026-01-08
13668-527-04GM - Gram13668-52761f2fca4-28a3-4067-a530-446b91de85ca12026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-527MOMETASONE FUROATE OINTMENT [TORRENT PHARMACEUTICALS LIMITED]7Current NDC, Legacy NDC, 2 package rows20250327_18ef90de-f74d-492f-a125-49da1875bd29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151029mometasone furoate 0.1 % Topical OintmentPSN18ef90de-f74d-492f-a125-49da1875bd298
151029mometasone furoate 0.001 MG/MG Topical OintmentSCD18ef90de-f74d-492f-a125-49da1875bd298
151029mometasone furoate 0.1 % Topical OintmentSY18ef90de-f74d-492f-a125-49da1875bd298
151029mometasone furoate 1 MG/GM Topical OintmentSY18ef90de-f74d-492f-a125-49da1875bd298

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-527-011366805270115 OINTMENT in 1 BOX (13668-527-01) 15 ointment2024-12-150000-00-00NoNoCurrent
13668-527-041366805270445 OINTMENT in 1 BOX (13668-527-04) 45 ointment2024-12-150000-00-00NoNoCurrent