FDA.reportPublic FDA data

Leader Allergy Nasal

Product NDC
70000-0635
11-digit product format
700000635
Labeler code
70000
Product ID
70000-0635_b06fcce1-b499-4f0d-a125-55d3ed7a3593
Type
HUMAN OTC DRUG
Nonproprietary name
mometasone furoate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
NDA215712
Marketing category
NDA
Marketing start
2023-09-22
Substance
MOMETASONE FUROATE MONOHYDRATE
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
Leader Allergy Nasal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOMETASONE FUROATE MONOHYDRATE50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMTW0WEG809
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
70000-0635-1Leader Allergy Nasal1 in 1 CARTONSPRAY, METERED15
70000-0635-1Leader Allergy Nasal60 in 1 BOTTLE, SPRAYSPRAY, METERED605
70000-0635-2Leader Allergy Nasal120 in 1 BOTTLE, SPRAYSPRAY, METERED1205
70000-0635-2Leader Allergy Nasal1 in 1 CARTONSPRAY, METERED15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0635-2ML - Milliliter70000-06358e18ef2e-d681-44e3-add0-ae7bf6da7f5912024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0635LEADER ALLERGY NASAL (MOMETASONE FUROATE) SPRAY, METERED [CARDINAL HEALTH 110, LLC. DBA LEADER]4Current NDC, 4 package rows20241205_26f929e8-0759-4584-a0bf-f7709baa6bee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797865mometasone furoate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN26f929e8-0759-4584-a0bf-f7709baa6bee5
1797865mometasone furoate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD26f929e8-0759-4584-a0bf-f7709baa6bee5
1797865mometasone furoate 50 MCG/ACTUAT Metered Dose Nasal SpraySY26f929e8-0759-4584-a0bf-f7709baa6bee5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70000-0635-1700000635011 BOTTLE, SPRAY in 1 CARTON (70000-0635-1) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY2023-09-22NoNoHistorical
70000-0635-2700000635021 BOTTLE, SPRAY in 1 CARTON (70000-0635-2) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY2023-09-22NoNoHistorical