FDA.reportPublic FDA data

AZELASTINE HYDROCHLORIDE

Product NDC
68788-8514
11-digit product format
687888514
Labeler code
68788
Product ID
68788-8514_9bc32bee-67cc-4e7c-a128-185235edc8c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZELASTINE HYDROCHLORIDE
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA212289
Marketing category
ANDA
Marketing start
2023-09-01
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
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 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
68788-8514-2AZELASTINE HYDROCHLORIDE200 in 1 BOTTLE, SPRAYSPRAY, METERED2004
68788-8514-2AZELASTINE HYDROCHLORIDE1 in 1 CARTONSPRAY, METERED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8514AZELASTINE HYDROCHLORIDE SPRAY, METERED [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 2 package rows20250207_37c40f8d-269c-4df8-8ac7-cbe78f4ca5c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797867azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal SprayPSN37c40f8d-269c-4df8-8ac7-cbe78f4ca5c44
1797867azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal SpraySCD37c40f8d-269c-4df8-8ac7-cbe78f4ca5c44
1797867azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal SpraySY37c40f8d-269c-4df8-8ac7-cbe78f4ca5c44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8514-2687888514021 BOTTLE, SPRAY in 1 CARTON (68788-8514-2) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY2023-09-01NoNoHistorical