FDA.reportPublic FDA data

Azelastine

Product NDC
67877-477
11-digit product format
678770477
Labeler code
67877
Product ID
67877-477_b5281403-77e2-44a3-966f-d9c9efb86453
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azelastine
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Ascend Laboratories, LLC
Application
ANDA208156
Marketing category
ANDA
Marketing start
2017-08-18
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67877-477-502022-09-20C16284748780-1e4f33bdf-ac70-d8a0-e053-dadaa90a6e4eThese 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
67877-477-502022-07-29C16284748780-1e4f33bdf-ac70-d8a0-e053-dadaa90a6e4eThese 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
67877-477-50Azelastine1 in 1 BOTTLESPRAY, METERED112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-477-50ML - Milliliter67877-477a421c428-5076-4a6c-8923-1fb92f9936b012017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-477AZELASTINE SPRAY, METERED [ASCEND LABORATORIES, LLC]11Current NDC, Legacy NDC, 1 package rows20240716_77b20c6b-f30f-42a9-a0ef-d5d0bd3feb56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797867azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal SprayPSN77b20c6b-f30f-42a9-a0ef-d5d0bd3feb5612
1797867azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal SpraySCD77b20c6b-f30f-42a9-a0ef-d5d0bd3feb5612
1797867azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal SpraySY77b20c6b-f30f-42a9-a0ef-d5d0bd3feb5612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-477-50678770477501 SPRAY, METERED in 1 BOTTLE (67877-477-50) 2017-08-180000-00-00NoNoCurrent