FDA.reportPublic FDA data

Azelastine Hydrochloride

Product NDC
0363-0653
11-digit product format
003630653
Labeler code
0363
Product ID
0363-0653_52478468-e6b9-4d34-9822-ee138abdecd8
Type
HUMAN OTC DRUG
Nonproprietary name
Azelastine Hydrochloride
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Walgreens
Application
ANDA216421
Marketing category
ANDA
Marketing start
2025-07-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Azelastine Hydrochloride
Listing expiration
2027-12-31

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
0363-0653-01Azelastine Hydrochloride60 in 1 BOTTLE, SPRAYSPRAY, METERED606
0363-0653-02Azelastine Hydrochloride120 in 1 BOTTLE, SPRAYSPRAY, METERED1206
0363-0653-03Azelastine Hydrochloride1 in 1 CARTONSPRAY, METERED16
0363-0653-04Azelastine Hydrochloride1 in 1 CARTONSPRAY, METERED16
0363-0653-05Azelastine Hydrochloride120 in 1 BOTTLE, SPRAYSPRAY, METERED1206
0363-0653-05Azelastine Hydrochloride2 in 1 CARTONSPRAY, METERED26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0653AZELASTINE HYDROCHLORIDE SPRAY, METERED [WALGREENS]2Current NDC, 6 package rows20250330_ec268981-433f-b26b-4ff0-3a121e0a0d08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797883azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal SprayPSNec268981-433f-b26b-4ff0-3a121e0a0d086
1797883azelastine hydrochloride 0.206 MG/ACTUAT Metered Dose Nasal SpraySCDec268981-433f-b26b-4ff0-3a121e0a0d086
1797883azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal SpraySYec268981-433f-b26b-4ff0-3a121e0a0d086

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0363-0653-010036306530160 in 1 BOTTLE, SPRAYHistorical
0363-0653-0200363065302120 SPRAY, METERED in 1 BOTTLE, SPRAY (0363-0653-02) 2025-07-01NoNoHistorical
0363-0653-03003630653031 BOTTLE, SPRAY in 1 CARTON (0363-0653-03) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY (0363-0653-01) 2025-07-01NoNoHistorical
0363-0653-04003630653041 BOTTLE, SPRAY in 1 CARTON (0363-0653-04) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY (0363-0653-02) 2025-07-01NoNoHistorical
0363-0653-05003630653052 BOTTLE, SPRAY in 1 CARTON (0363-0653-05) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY2025-07-01NoNoHistorical