FDA.reportPublic FDA data

AZELASTINE HYDROCHLORIDE

Product NDC
59651-214
11-digit product format
596510214
Labeler code
59651
Product ID
59651-214_c3f16181-99f1-406c-b795-d33ff0da7ef6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZELASTINE HYDROCHLORIDE
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Aurobindo Pharma Limited
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
59651-214-30AZELASTINE HYDROCHLORIDE1 in 1 CARTONSPRAY, METERED18
59651-214-30AZELASTINE HYDROCHLORIDE200 in 1 BOTTLE, SPRAYSPRAY, METERED2008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-214AZELASTINE HYDROCHLORIDE SPRAY, METERED [AUROBINDO PHARMA LIMITED]8Current NDC, Legacy NDC, 2 package rows20240518_97c91a09-98d0-4666-8448-0bd50c02bb14.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797867azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal SprayPSN97c91a09-98d0-4666-8448-0bd50c02bb148
1797867azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal SpraySCD97c91a09-98d0-4666-8448-0bd50c02bb148
1797867azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal SpraySY97c91a09-98d0-4666-8448-0bd50c02bb148
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
1797867azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal SprayPSN74de4d22-e6e0-4050-bf86-403ca6945cce2
1797867azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal SpraySCD74de4d22-e6e0-4050-bf86-403ca6945cce2
1797867azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal SpraySY74de4d22-e6e0-4050-bf86-403ca6945cce2
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 startMarketing endSampleExclude flagStatus
59651-214-30596510214301 BOTTLE, SPRAY in 1 CARTON (59651-214-30) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY2020-05-080000-00-00NoNoCurrent