Home NDC 47335-779 Azelastine Hydrochloride
Product NDC 47335-779
11-digit product format 473350779
Labeler code 47335
Product ID 47335-779_09652cb1-7315-4188-9f36-4e2b50fb764d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azelastine Hydrochloride
Dosage form SPRAY, METERED
Route NASAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA090423
Marketing category ANDA
Marketing start 2012-05-24
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 A090423-001 AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL 2012-05-23
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 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL 2012-05-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL 2012-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL 2012-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL 2012-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL 2012-05-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL 2012-05-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL 2012-05-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL 2012-05-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090423-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090423-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090423-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090423-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090423-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090423-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090423-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090423-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090423-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2012-05-23 e64feba35796…
Observed Orange Book normalized TE history# 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 47335-779-91 Azelastine Hydrochloride 1 in 1 BOX SPRAY, METERED 1 9 47335-779-91 Azelastine Hydrochloride 200 in 1 BOTTLE, SPRAY SPRAY, METERED 200 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AZELASTINE HYDROCHLORIDE ACTIVE INGREDIENT 0L591QR10I AZELASTINE HYDROCHLORIDE SPRAY, METERED [SUN PHARMA GLOBAL FZE] 4 AZELASTINE ACTIVE MOIETY ZQI909440X AZELASTINE HYDROCHLORIDE SPRAY, METERED [SUN PHARMA GLOBAL FZE] 4 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL AZELASTINE HYDROCHLORIDE SPRAY, METERED [SUN PHARMA GLOBAL FZE] 4 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 AZELASTINE HYDROCHLORIDE SPRAY, METERED [SUN PHARMA GLOBAL FZE] 4 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K AZELASTINE HYDROCHLORIDE SPRAY, METERED [SUN PHARMA GLOBAL FZE] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO AZELASTINE HYDROCHLORIDE SPRAY, METERED [SUN PHARMA GLOBAL FZE] 4 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X AZELASTINE HYDROCHLORIDE SPRAY, METERED [SUN PHARMA GLOBAL FZE] 4 SODIUM PHOSPHATE, DIBASIC INACTIVE INGREDIENT GR686LBA74 AZELASTINE HYDROCHLORIDE SPRAY, METERED [SUN PHARMA GLOBAL FZE] 4 WATER INACTIVE INGREDIENT 059QF0KO0R AZELASTINE HYDROCHLORIDE SPRAY, METERED [SUN PHARMA GLOBAL FZE] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47335-779 AZELASTINE HYDROCHLORIDE SPRAY, METERED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 9 Current NDC, Legacy NDC, 2 package rows 20181214_305c6dc8-8247-473d-9975-b02903af6d53.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 Marketing start Marketing end Sample Exclude flag Status 47335-779-91 47335077991 1 BOTTLE, SPRAY in 1 BOX (47335-779-91) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY 2012-05-24 0000-00-00 No No Current