Home NDC 73581-500 AZELASTINE HYDROCHLORIDE
Product NDC 73581-500
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216561-001 AZELASTINE HYDROCHLORIDE ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED / NASAL 2025-01-27
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A216561-001 AZELASTINE HYDROCHLORIDE ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2025-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216561-001 AZELASTINE HYDROCHLORIDE ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2025-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216561-001 AZELASTINE HYDROCHLORIDE ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2025-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216561-001 AZELASTINE HYDROCHLORIDE ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2025-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216561-001 AZELASTINE HYDROCHLORIDE ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2025-01-27 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216561-001 AZELASTINE HYDROCHLORIDE ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2025-01-27 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base AZELASTINE HYDROCHLORIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AZELASTINE HYDROCHLORIDE 205.5 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0L591QR10I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1797883 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Status 73581-500-01 73581050001 1 BOTTLE, SPRAY in 1 CARTON (73581-500-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY 2026-07-14 0 Current 73581-500-02 73581050002 2 BOTTLE, SPRAY in 1 CARTON (73581-500-02) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY 2026-07-14 0 Current