FDA.reportPublic FDA data

Azelastine Hydrochloride

Product NDC
71205-449
11-digit product format
712050449
Labeler code
71205
Product ID
71205-449_91c72454-515f-4966-ad84-a78aba616fb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azelastine hydrochloride
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Proficient Rx LP
Application
ANDA077954
Marketing category
ANDA
Marketing start
2010-03-01
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
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
85ee67c3-6973-4172-9ada-b124d28b42f8Product name520210528
6397aa5d-11e2-42ce-b46f-ac49599ccf00Product name520201006
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
033d5d5b-187f-1f40-1e5a-11d732813f92Product name420200626
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-449-30Azelastine Hydrochloride200 in 1 BOTTLE, SPRAYSPRAY, METERED2004
71205-449-30Azelastine Hydrochloride1 in 1 CARTONSPRAY, METERED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-449-30ML - Milliliter71205-4493e174930-0978-4bc8-ba7a-783d0cbb7d1412020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-449AZELASTINE HYDROCHLORIDE SPRAY, METERED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 2 package rows20231005_11a74cae-a15b-4a6b-a8c0-1e6a234ee258.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797867azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal SprayPSN11a74cae-a15b-4a6b-a8c0-1e6a234ee2584
1797867azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal SpraySCD11a74cae-a15b-4a6b-a8c0-1e6a234ee2584
1797867azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal SpraySY11a74cae-a15b-4a6b-a8c0-1e6a234ee2584

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-449-30712050449301 BOTTLE, SPRAY in 1 CARTON (71205-449-30) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY2020-04-010000-00-00NoNoCurrent