FDA.reportPublic FDA data

AZELASTINE HYDROCHLORIDE

Product NDC
69168-478
11-digit product format
691680478
Labeler code
69168
Product ID
69168-478_fc930f5c-a2b9-4e66-814d-ca8d68cc2d29
Type
HUMAN OTC DRUG
Nonproprietary name
AZELASTINE HYDROCHLORIDE
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Allegiant Health
Application
ANDA216421
Marketing category
ANDA
Marketing start
2025-05-02
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-478-02AZELASTINE HYDROCHLORIDE120 in 1 BOTTLE, SPRAYSPRAY, METERED1206
69168-478-02AZELASTINE HYDROCHLORIDE2 in 1 CARTONSPRAY, METERED26
69168-478-63AZELASTINE HYDROCHLORIDE120 in 1 BOTTLE, SPRAYSPRAY, METERED1206
69168-478-63AZELASTINE HYDROCHLORIDE1 in 1 CARTONSPRAY, METERED16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-478AZELASTINE HYDROCHLORIDE SPRAY, METERED [ALLEGIANT HEALTH]2Current NDC, 4 package rows20250504_3e2fdb0d-c2f5-41ab-b1cd-4fae80648112.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797883azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal SprayPSN3e2fdb0d-c2f5-41ab-b1cd-4fae806481126
1797883azelastine hydrochloride 0.206 MG/ACTUAT Metered Dose Nasal SpraySCD3e2fdb0d-c2f5-41ab-b1cd-4fae806481126
1797883azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal SpraySY3e2fdb0d-c2f5-41ab-b1cd-4fae806481126

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69168-478-02691680478022 BOTTLE, SPRAY in 1 CARTON (69168-478-02) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY2025-09-22NoNoHistorical
69168-478-63691680478631 BOTTLE, SPRAY in 1 CARTON (69168-478-63) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY2025-09-22NoNoHistorical