Mometasone furoate

Product NDC
21922-071
11-digit product format
219220071
Labeler code
21922
Product ID
21922-071_2221a9e5-8710-4939-aa22-c9a4033d9f06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone furoate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
ANDA076481
Marketing category
ANDA
Marketing start
2026-04-07
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
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/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
21922-071-04Mometasone furoate1 in 1 CARTONOINTMENT11
21922-071-04Mometasone furoate15 g in 1 TUBEOINTMENT151
21922-071-06Mometasone furoate1 in 1 CARTONOINTMENT11
21922-071-06Mometasone furoate45 g in 1 TUBEOINTMENT451

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151029mometasone furoate 0.1 % Topical OintmentPSNdae3eaea-fc17-48a2-ae30-2a68f7811bce1
151029mometasone furoate 0.001 MG/MG Topical OintmentSCDdae3eaea-fc17-48a2-ae30-2a68f7811bce1
151029mometasone furoate 0.1 % Topical OintmentSYdae3eaea-fc17-48a2-ae30-2a68f7811bce1
151029mometasone furoate 1 MG/GM Topical OintmentSYdae3eaea-fc17-48a2-ae30-2a68f7811bce1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21922-071-04219220071041 TUBE in 1 CARTON (21922-071-04) / 15 g in 1 TUBE1 tube2026-04-07NoNoHistorical
21922-071-06219220071061 TUBE in 1 CARTON (21922-071-06) / 45 g in 1 TUBE1 tube2026-04-07NoNoHistorical