FDA.reportPublic FDA data

MOMETASONE FUROATE

Product NDC
60429-664
11-digit product format
604290664
Labeler code
60429
Product ID
60429-664_3998042c-0e58-e8c8-e063-6294a90ad173
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MOMETASONE FUROATE
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA091161
Marketing category
ANDA
Marketing start
2016-03-22
Substance
MOMETASONE
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
MOMETASONE50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8HR4QJ6DW8
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
60429-664-17MOMETASONE FUROATE1 in 1 CARTONSPRAY, METERED112
60429-664-17MOMETASONE FUROATE120 in 1 BOTTLE, PUMPSPRAY, METERED12012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-664-17GM - Gram60429-664d036bf34-b9f6-411a-a992-201e2fa83d0512016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-664MOMETASONE FUROATE SPRAY, METERED [GOLDEN STATE MEDICAL SUPPLY, INC.]11Current NDC, Legacy NDC, 2 package rows20250226_e30ca373-d9c0-4cad-b5c3-3be9c299dddc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797865mometasone furoate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNe30ca373-d9c0-4cad-b5c3-3be9c299dddc12
1797865mometasone furoate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDe30ca373-d9c0-4cad-b5c3-3be9c299dddc12
1797865mometasone furoate 50 MCG/ACTUAT Metered Dose Nasal SpraySYe30ca373-d9c0-4cad-b5c3-3be9c299dddc12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-664-17604290664171 BOTTLE, PUMP in 1 CARTON (60429-664-17) / 120 SPRAY, METERED in 1 BOTTLE, PUMP2016-03-290000-00-00NoNoCurrent