FDA.reportPublic FDA data

AZELASTINE HYDROCHLORIDE

Product NDC
58602-020
11-digit product format
586020020
Labeler code
58602
Product ID
58602-020_408b5706-3b4c-4eaf-8d03-b4e26485c06b
Type
HUMAN OTC DRUG
Nonproprietary name
AZELASTINE HYDROCHLORIDE
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Aurohealth LLC
Application
ANDA216561
Marketing category
ANDA
Marketing start
2025-01-27
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216561-001AZELASTINE HYDROCHLORIDE ALLERGYAZELASTINE HYDROCHLORIDE0.2055MG/SPRAYSPRAY, METERED / NASAL2025-01-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A216561-001AZELASTINE HYDROCHLORIDE ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2025-01-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216561-001AZELASTINE HYDROCHLORIDE ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2025-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216561-001AZELASTINE HYDROCHLORIDE ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2025-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A216561-001AZELASTINE HYDROCHLORIDE ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2025-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216561-001AZELASTINE HYDROCHLORIDE ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2025-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216561-001AZELASTINE HYDROCHLORIDE ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2025-01-27b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216561-001AZELASTINE HYDROCHLORIDE ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2025-01-27a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
AZELASTINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0L591QR10IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1797883Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7281c597-651e-4425-8208-7637cd9d3500Available on FDA.report

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
58602-020-07AZELASTINE HYDROCHLORIDE1 in 1 CARTONSPRAY, METERED12
58602-020-07AZELASTINE HYDROCHLORIDE200 in 1 BOTTLE, SPRAYSPRAY, METERED2002
58602-020-51AZELASTINE HYDROCHLORIDE60 in 1 BOTTLE, SPRAYSPRAY, METERED602
58602-020-51AZELASTINE HYDROCHLORIDE1 in 1 CARTONSPRAY, METERED12
58602-020-52AZELASTINE HYDROCHLORIDE120 in 1 BOTTLE, SPRAYSPRAY, METERED1202
58602-020-52AZELASTINE HYDROCHLORIDE1 in 1 CARTONSPRAY, METERED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-020AZELASTINE HYDROCHLORIDE SPRAY, METERED [AUROHEALTH LLC]1Current NDC, 6 package rows20250205_7281c597-651e-4425-8208-7637cd9d3500.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEYYBA Corp52f67910-11a7-6e7d-e063-6394a90ac9e82026-07-22WarningsExact identifier
application applno (ANDA): 216561
application number: ANDA216561
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEAurohealth LLC7281c597-651e-4425-8208-7637cd9d35002025-12-15WarningsExact identifier
application applno (ANDA): 216561
application number: ANDA216561
ndc (product): 58602-020

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797883azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal SprayPSN7281c597-651e-4425-8208-7637cd9d35002
1797883azelastine hydrochloride 0.206 MG/ACTUAT Metered Dose Nasal SpraySCD7281c597-651e-4425-8208-7637cd9d35002
1797883azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal SpraySY7281c597-651e-4425-8208-7637cd9d35002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
58602-020-07586020020071 BOTTLE, SPRAY in 1 CARTON (58602-020-07) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY2025-01-27NoNoCurrent
58602-020-51586020020511 BOTTLE, SPRAY in 1 CARTON (58602-020-51) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY2025-01-27NoNoCurrent
58602-020-52586020020521 BOTTLE, SPRAY in 1 CARTON (58602-020-52) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY2025-01-27NoNoCurrent