FDA.reportPublic FDA data

AZELASTINE HYDROCHLORIDE

Product NDC
50090-7461
11-digit product format
500907461
Labeler code
50090
Product ID
50090-7461_6f0629d0-5f20-406f-ad61-cf775f553772
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZELASTINE HYDROCHLORIDE
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
A-S Medication Solutions
Application
ANDA212289
Marketing category
ANDA
Marketing start
2020-05-08
Substance
AZELASTINE HYDROCHLORIDE
Active strength
137 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 HYDROCHLORIDE137 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0L591QR10I
Rxcui1797867

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
50090-7461-0AZELASTINE HYDROCHLORIDE200 in 1 BOTTLE, SPRAYSPRAY, METERED2001
50090-7461-0AZELASTINE HYDROCHLORIDE1 in 1 CARTONSPRAY, METERED11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7461-0ML - Milliliter50090-7461bc6882c5-e269-4681-a4e2-5f8a26c4828712024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7461AZELASTINE HYDROCHLORIDE SPRAY, METERED [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20241122_fc9d031d-428d-4d53-8e63-feb96d5ab01a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797867azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal SprayPSNfc9d031d-428d-4d53-8e63-feb96d5ab01a1
1797867azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal SpraySCDfc9d031d-428d-4d53-8e63-feb96d5ab01a1
1797867azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal SpraySYfc9d031d-428d-4d53-8e63-feb96d5ab01a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7461-0500907461001 BOTTLE, SPRAY in 1 CARTON (50090-7461-0) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY2024-11-19NoNoCurrent