FDA.reportPublic FDA data

AZELASTINE HYDROCHLORIDE

Product NDC
58602-020
11-digit product format
586020020
Labeler code
58602
Product ID
58602-020_408b5706-3b4c-4eaf-8d03-b4e26485c06b
Type
HUMAN OTC DRUG
Nonproprietary name
AZELASTINE HYDROCHLORIDE
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Aurohealth LLC
Application
ANDA216561
Marketing category
ANDA
Marketing start
2025-01-27
Substance
AZELASTINE HYDROCHLORIDE
Active strength
205.5 ug/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AZELASTINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZELASTINE HYDROCHLORIDE205.5 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0L591QR10I
Rxcui1797883

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33Product name320260126
85ee67c3-6973-4172-9ada-b124d28b42f8Product name520210528
6397aa5d-11e2-42ce-b46f-ac49599ccf00Product name520201006
033d5d5b-187f-1f40-1e5a-11d732813f92Product name420200626

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-020-07AZELASTINE HYDROCHLORIDE1 in 1 CARTONSPRAY, METERED12
58602-020-07AZELASTINE HYDROCHLORIDE200 in 1 BOTTLE, SPRAYSPRAY, METERED2002
58602-020-51AZELASTINE HYDROCHLORIDE60 in 1 BOTTLE, SPRAYSPRAY, METERED602
58602-020-51AZELASTINE HYDROCHLORIDE1 in 1 CARTONSPRAY, METERED12
58602-020-52AZELASTINE HYDROCHLORIDE120 in 1 BOTTLE, SPRAYSPRAY, METERED1202
58602-020-52AZELASTINE HYDROCHLORIDE1 in 1 CARTONSPRAY, METERED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-020AZELASTINE HYDROCHLORIDE SPRAY, METERED [AUROHEALTH LLC]1Current NDC, 6 package rows20250205_7281c597-651e-4425-8208-7637cd9d3500.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797883azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal SprayPSN7281c597-651e-4425-8208-7637cd9d35002
1797883azelastine hydrochloride 0.206 MG/ACTUAT Metered Dose Nasal SpraySCD7281c597-651e-4425-8208-7637cd9d35002
1797883azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal SpraySY7281c597-651e-4425-8208-7637cd9d35002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
58602-020-07586020020071 BOTTLE, SPRAY in 1 CARTON (58602-020-07) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY2025-01-27NoNoCurrent
58602-020-51586020020511 BOTTLE, SPRAY in 1 CARTON (58602-020-51) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY2025-01-27NoNoCurrent
58602-020-52586020020521 BOTTLE, SPRAY in 1 CARTON (58602-020-52) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY2025-01-27NoNoCurrent