FDA.reportPublic FDA data

Azelastine Hydrochloride

Product NDC
61314-308
11-digit product format
613140308
Labeler code
61314
Product ID
61314-308_8d1b371d-f84a-4054-9a54-7cde00000f81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azelastine hydrochloride
Dosage form
SOLUTION/ DROPS
Route
INTRAOCULAR
Labeler
Sandoz Inc
Application
ANDA202305
Marketing category
ANDA
Marketing start
2013-03-21
Substance
AZELASTINE HYDROCHLORIDE
Active strength
.5 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 HYDROCHLORIDE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0L591QR10I
Rxcui860805

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
61314-308-02Azelastine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS14
61314-308-02Azelastine Hydrochloride6 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS64

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-308-02ML - Milliliter61314-308a32259e5-267e-454f-aa5d-6e5898aaa2e512013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZELASTINE HYDROCHLORIDEACTIVE INGREDIENT0L591QR10IAZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC]1
AZELASTINEACTIVE MOIETYZQI909440XAZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7AZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IAZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC]1
SORBITOLINACTIVE INGREDIENT506T60A25RAZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC]1
WATERINACTIVE INGREDIENT059QF0KO0RAZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-308AZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC]4Current NDC, Legacy NDC, 2 package rows20220212_6945fb86-27fb-4bab-8908-98772c6269c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860805azelastine HCl 0.05 % Ophthalmic SolutionPSN6945fb86-27fb-4bab-8908-98772c6269c54
860805azelastine hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD6945fb86-27fb-4bab-8908-98772c6269c54
860805azelastine hydrochloride 0.05 % Ophthalmic SolutionSY6945fb86-27fb-4bab-8908-98772c6269c54
860805azelastine HCl 0.05 % Ophthalmic SolutionPSN31cf2bd9-fbb5-4931-9202-9784d8d6aad02
860805azelastine hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD31cf2bd9-fbb5-4931-9202-9784d8d6aad02
860805azelastine hydrochloride 0.05 % Ophthalmic SolutionSY31cf2bd9-fbb5-4931-9202-9784d8d6aad02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61314-308-02613140308021 BOTTLE, PLASTIC in 1 CARTON (61314-308-02) / 6 mL in 1 BOTTLE, PLASTIC2013-03-210000-00-00NoNoCurrent