FDA.reportPublic FDA data

Azelastine Hydrochloride

Product NDC
42291-094
11-digit product format
422910094
Labeler code
42291
Product ID
42291-094_485b8c18-0782-37ea-e063-6394a90ad61e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azelastine
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
AvKARE
Application
ANDA204660
Marketing category
ANDA
Marketing start
2021-03-03
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
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-094-30Azelastine Hydrochloride1 in 1 CARTONSPRAY, METERED14
42291-094-30Azelastine Hydrochloride30 mL in 1 BOTTLE, SPRAYSPRAY, METERED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-094-30ML - Milliliter42291-094306a2276-4fb7-4410-9a74-943e0770046212021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-094AZELASTINE HYDROCHLORIDE (AZELASTINE) SPRAY, METERED [AVKARE]3Current NDC, Legacy NDC, 2 package rows20240110_bca75501-4140-4d77-e053-2a95a90a019f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797867azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal SprayPSNbca75501-4140-4d77-e053-2a95a90a019f4
1797867azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal SpraySCDbca75501-4140-4d77-e053-2a95a90a019f4
1797867azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal SpraySYbca75501-4140-4d77-e053-2a95a90a019f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-094-30422910094301 BOTTLE, SPRAY in 1 CARTON (42291-094-30) / 30 mL in 1 BOTTLE, SPRAY2021-03-030000-00-00NoNoCurrent