FDA.reportPublic FDA data

Azelastine Hydrochloride

Product NDC
51316-840
11-digit product format
513160840
Labeler code
51316
Product ID
51316-840_996da2f2-ced4-407a-acd6-4c72036c51ef
Type
HUMAN OTC DRUG
Nonproprietary name
Azelastine Hydrochloride
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
CVS PHARMACY, INC
Application
ANDA216421
Marketing category
ANDA
Marketing start
2025-08-01
Substance
AZELASTINE HYDROCHLORIDE
Active strength
205.5 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 Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZELASTINE HYDROCHLORIDE205.5 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0L591QR10I
Rxcui1797883

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-840-01Azelastine Hydrochloride1 in 1 CARTONSPRAY, METERED15
51316-840-02Azelastine Hydrochloride120 in 1 BOTTLE, SPRAYSPRAY, METERED1205
51316-840-03Azelastine Hydrochloride1 in 1 CARTONSPRAY, METERED15
51316-840-03Azelastine Hydrochloride60 in 1 BOTTLE, SPRAYSPRAY, METERED605
51316-840-04Azelastine Hydrochloride60 in 1 BOTTLE, SPRAYSPRAY, METERED605
51316-840-05Azelastine Hydrochloride2 in 1 CARTONSPRAY, METERED25
51316-840-05Azelastine Hydrochloride120 in 1 BOTTLE, SPRAYSPRAY, METERED1205

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797883azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal SprayPSN22d516d0-da22-4e3b-a4a5-135b009bc9685
1797883azelastine hydrochloride 0.206 MG/ACTUAT Metered Dose Nasal SpraySCD22d516d0-da22-4e3b-a4a5-135b009bc9685
1797883azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal SpraySY22d516d0-da22-4e3b-a4a5-135b009bc9685

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51316-840-01513160840011 BOTTLE, SPRAY in 1 CARTON (51316-840-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY (51316-840-02) 2025-08-01NoNoHistorical
51316-840-0251316084002120 SPRAY, METERED in 1 BOTTLE, SPRAY (51316-840-02) 2025-08-01NoNoHistorical
51316-840-03513160840031 BOTTLE, SPRAY in 1 CARTON (51316-840-03) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY2025-08-01NoNoHistorical
51316-840-045131608400460 SPRAY, METERED in 1 BOTTLE, SPRAY (51316-840-04) 2025-08-01NoNoHistorical
51316-840-05513160840052 BOTTLE, SPRAY in 1 CARTON (51316-840-05) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY2025-08-01NoNoHistorical