FDA.reportPublic FDA data

Mometasone Furoate

Product NDC
65162-891
11-digit product format
651620891
Labeler code
65162
Product ID
65162-891_d6a5b296-7bb8-4a4c-b9f1-2f7fe70a50cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA207989
Marketing category
ANDA
Marketing start
2017-04-04
Substance
MOMETASONE FUROATE
Active strength
50 ug/1
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 FUROATE50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04201GDN4R
Rxcui1797865

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
65162-891-29Mometasone Furoate120 in 1 BOTTLE, PUMPSPRAY, METERED12013
65162-891-29Mometasone Furoate1 in 1 CARTONSPRAY, METERED113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-891-29GM - Gram65162-891ad9bc177-ca22-479d-b1d8-324d8e2e98d912017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-891MOMETASONE FUROATE (MOMETASONE) SPRAY, METERED [AMNEAL PHARMACEUTICALS LLC]13Current NDC, Legacy NDC, 2 package rows20240117_ff41e901-5a6f-4ad5-be8a-a68eae787e5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797865mometasone furoate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNff41e901-5a6f-4ad5-be8a-a68eae787e5e13
1797865mometasone furoate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDff41e901-5a6f-4ad5-be8a-a68eae787e5e13
1797865mometasone furoate 50 MCG/ACTUAT Metered Dose Nasal SpraySYff41e901-5a6f-4ad5-be8a-a68eae787e5e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-891-29651620891291 BOTTLE, PUMP in 1 CARTON (65162-891-29) / 120 SPRAY, METERED in 1 BOTTLE, PUMP2017-04-040000-00-00NoNoCurrent