FDA.reportPublic FDA data

Azelastine Hydrochloride

Product NDC
65162-676
11-digit product format
651620676
Labeler code
65162
Product ID
65162-676_0ead3061-d60d-4911-91cc-489d3b5fe573
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azelastine
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA204660
Marketing category
ANDA
Marketing start
2017-09-05
Substance
AZELASTINE HYDROCHLORIDE
Active strength
1 mg/mL
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 HYDROCHLORIDE1 mg/mL

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65162-676-842024-03-11C16284748780-11030e365-5709-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AZELASTINE HYDROCHLORIDE NASAL SPRAY safely and effectively. See full prescribing information for AZELASTINE HYDROCHLORIDE NASAL SPRAY. AZELASTINE HYDROCHLORIDE nasal spray, for intranasal use Initial U.S. Approval: 1996
65162-676-842024-01-30C16284748780-11030e365-5709-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AZELASTINE HYDROCHLORIDE NASAL SPRAY safely and effectively. See full prescribing information for AZELASTINE HYDROCHLORIDE NASAL SPRAY. AZELASTINE HYDROCHLORIDE nasal spray, for intranasal use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-676-84Azelastine Hydrochloride30 mL in 1 BOTTLE, SPRAYSPRAY, METERED3012
65162-676-84Azelastine Hydrochloride1 in 1 CARTONSPRAY, METERED112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-676-84ML - Milliliter65162-6768ef5a624-adb7-4755-ae9f-63835bf24f8f12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-676AZELASTINE HYDROCHLORIDE (AZELASTINE) SPRAY, METERED [AMNEAL PHARMACEUTICALS LLC]12Current NDC, Legacy NDC, 2 package rows20240312_7902605c-944a-4d7e-a7d4-eb4a71bcacdb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797867azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal SprayPSN7902605c-944a-4d7e-a7d4-eb4a71bcacdb12
1797867azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal SpraySCD7902605c-944a-4d7e-a7d4-eb4a71bcacdb12
1797867azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal SpraySY7902605c-944a-4d7e-a7d4-eb4a71bcacdb12
1797867azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal SprayPSNa710e553-9ce8-4c92-a186-1649ec10b88d5
1797867azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal SpraySCDa710e553-9ce8-4c92-a186-1649ec10b88d5
1797867azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal SpraySYa710e553-9ce8-4c92-a186-1649ec10b88d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-676-84651620676841 BOTTLE, SPRAY in 1 CARTON (65162-676-84) / 30 mL in 1 BOTTLE, SPRAY2017-09-050000-00-00NoNoCurrent