FDA.reportPublic FDA data

AZELASTINE HYDROCHLORIDE

Product NDC
73581-500
Requested package NDC
73581-500-01
11-digit product format
735810500
Labeler code
73581
Product ID
73581-500_57343d7c-0900-e362-e063-6394a90afc09
Type
HUMAN OTC DRUG
Nonproprietary name
AZELASTINE HYDROCHLORIDE
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
YYBA Corp
Application
ANDA216561
Marketing category
ANDA
Marketing start
2026-07-14
Substance
AZELASTINE HYDROCHLORIDE
Active strength
205.5 ug/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA]; Histamine-1 Receptor Antagonist [EPC]
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
2026-02-19 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
2027-12-31

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
52f67910-11a7-6e7d-e063-6394a90ac9e8Available on FDA.report

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
ndc (package): 73581-500-01
ndc (product): 73581-500
ndc11 (package): 73581050001
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEAurohealth LLC7281c597-651e-4425-8208-7637cd9d35002025-12-15WarningsExact identifier
application applno (ANDA): 216561
application number: ANDA216561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleStatus
73581-500-01735810500011 BOTTLE, SPRAY in 1 CARTON (73581-500-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY2026-07-140Current