Home NDC 0363-0653 Azelastine Hydrochloride
Product NDC 0363-0653
11-digit product format 003630653
Labeler code 0363
Product ID 0363-0653_52478468-e6b9-4d34-9822-ee138abdecd8
Type HUMAN OTC DRUG
Nonproprietary name Azelastine Hydrochloride
Dosage form SPRAY, METERED
Route NASAL
Labeler Walgreens
Application ANDA216421
Marketing category ANDA
Marketing start 2025-07-01
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216421-001 AZELASTINE HYDROCHLORIDE ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 A216421-002 AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29
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 2026-10-15 13:18:30 2026-09 A216421-001 AZELASTINE HYDROCHLORIDE ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 A216421-002 AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 A216421-001 AZELASTINE HYDROCHLORIDE ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216421-002 AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216421-001 AZELASTINE HYDROCHLORIDE ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216421-002 AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216421-001 AZELASTINE HYDROCHLORIDE ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216421-002 AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216421-001 AZELASTINE HYDROCHLORIDE ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216421-002 AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216421-001 AZELASTINE HYDROCHLORIDE ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216421-002 AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216421-001 AZELASTINE HYDROCHLORIDE ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216421-002 AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216421-001 AZELASTINE HYDROCHLORIDE ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216421-002 AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216421-001 AZELASTINE HYDROCHLORIDE ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216421-002 AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216421-001 AZELASTINE HYDROCHLORIDE ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216421-002 AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216421-001 AZELASTINE HYDROCHLORIDE ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216421-002 AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216421-001 AZELASTINE HYDROCHLORIDE ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216421-002 AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216421-001 AZELASTINE HYDROCHLORIDE ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216421-002 AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216421-001 AZELASTINE HYDROCHLORIDE ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216421-002 AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216421-001 AZELASTINE HYDROCHLORIDE ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216421-002 AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216421-001 AZELASTINE HYDROCHLORIDE ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216421-002 AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216421-001 AZELASTINE HYDROCHLORIDE ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216421-002 AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-05-29 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0363-0653-01 Azelastine Hydrochloride 60 in 1 BOTTLE, SPRAY SPRAY, METERED 60 6 0363-0653-02 Azelastine Hydrochloride 120 in 1 BOTTLE, SPRAY SPRAY, METERED 120 6 0363-0653-03 Azelastine Hydrochloride 1 in 1 CARTON SPRAY, METERED 1 6 0363-0653-04 Azelastine Hydrochloride 1 in 1 CARTON SPRAY, METERED 1 6 0363-0653-05 Azelastine Hydrochloride 120 in 1 BOTTLE, SPRAY SPRAY, METERED 120 6 0363-0653-05 Azelastine Hydrochloride 2 in 1 CARTON SPRAY, METERED 2 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-0653 AZELASTINE HYDROCHLORIDE SPRAY, METERED [WALGREENS] 2 Current NDC, 6 package rows 20250330_ec268981-433f-b26b-4ff0-3a121e0a0d08.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0363-0653-01 00363065301 60 in 1 BOTTLE, SPRAY Historical 0363-0653-02 00363065302 120 SPRAY, METERED in 1 BOTTLE, SPRAY (0363-0653-02) 2025-07-01 No No Current 0363-0653-03 00363065303 1 BOTTLE, SPRAY in 1 CARTON (0363-0653-03) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY (0363-0653-01) 2025-07-01 No No Current 0363-0653-04 00363065304 1 BOTTLE, SPRAY in 1 CARTON (0363-0653-04) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY (0363-0653-02) 2025-07-01 No No Current 0363-0653-05 00363065305 2 BOTTLE, SPRAY in 1 CARTON (0363-0653-05) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY 2025-07-01 No No Current