Home NDC 71205-449 Azelastine Hydrochloride
Product NDC 71205-449
11-digit product format 712050449
Labeler code 71205
Product ID 71205-449_91c72454-515f-4966-ad84-a78aba616fb5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name azelastine hydrochloride
Dosage form SPRAY, METERED
Route NASAL
Labeler Proficient Rx LP
Application ANDA077954
Marketing category ANDA
Marketing start 2010-03-01
Substance AZELASTINE HYDROCHLORIDE
Active strength 137 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 A077954-001 AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077954-001 AB
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.
Product history page 1 of 2 · 42 observed 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 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077954-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2009-04-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077954-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2009-04-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077954-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2009-04-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077954-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2009-04-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077954-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2009-04-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077954-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2009-04-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077954-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2009-04-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077954-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2009-04-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077954-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB RS 2009-04-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Azelastine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AZELASTINE HYDROCHLORIDE 137 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 1797867 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 71205-449-30 Azelastine Hydrochloride 200 in 1 BOTTLE, SPRAY SPRAY, METERED 200 4 71205-449-30 Azelastine Hydrochloride 1 in 1 CARTON SPRAY, METERED 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-449 AZELASTINE HYDROCHLORIDE SPRAY, METERED [PROFICIENT RX LP] 4 Current NDC, Legacy NDC, 2 package rows 20231005_11a74cae-a15b-4a6b-a8c0-1e6a234ee258.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71205-449-30 71205044930 1 BOTTLE, SPRAY in 1 CARTON (71205-449-30) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY 2020-04-01 0000-00-00 No No Current