Home NDC 69238-2147 Azelastine HCl
Product NDC 69238-2147
11-digit product format 692382147
Labeler code 69238
Product ID 69238-2147_125e35a1-2e6f-4646-aad2-d6465917671c
Type HUMAN OTC DRUG
Nonproprietary name Azelastine
Dosage form SPRAY, METERED
Route NASAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA216576
Marketing category ANDA
Marketing start 2024-06-07
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216576-001 AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-06-05
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 2026-08-18 06:07:40 2026-07 A216576-001 AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-06-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216576-001 AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-06-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216576-001 AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-06-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216576-001 AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-06-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216576-001 AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-06-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216576-001 AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-06-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216576-001 AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-06-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216576-001 AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-06-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216576-001 AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-06-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216576-001 AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-06-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216576-001 AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-06-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216576-001 AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-06-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216576-001 AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-06-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216576-001 AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-06-05 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216576-001 AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED / NASAL 2024-06-05 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Azelastine HCl
Listing expiration 2026-12-31 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 69238-2147-3 Azelastine HCl 1 in 1 CARTON SPRAY, METERED 1 10 69238-2147-3 Azelastine HCl 200 in 1 BOTTLE SPRAY, METERED 200 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-2147 AZELASTINE HCL (AZELASTINE) SPRAY, METERED [AMNEAL PHARMACEUTICALS NY LLC] 9 Current NDC, 2 package rows 20240608_82610437-25f4-4ae0-9d6a-381e9932f87d.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69238-2147-3 69238214703 200 CARTON in 1 BOTTLE (69238-2147-3) / 1 SPRAY, METERED in 1 CARTON 200 carton 2024-06-07 No No Current