Home NDC 72266-141 Azelastine Hydrochloride
Product NDC 72266-141
11-digit product format 722660141
Labeler code 72266
Product ID 72266-141_4613d423-9c03-f7d0-e063-6394a90a6a9c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azelastine Hydrochloride
Dosage form SOLUTION/ DROPS
Route INTRAOCULAR
Labeler Fosun Pharma USA Inc
Application ANDA210092
Marketing category ANDA
Marketing start 2020-09-08
Substance AZELASTINE HYDROCHLORIDE
Active strength .5 mg/mL
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 20 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 72266-141-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 72266-141-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 72266-141-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 72266-141-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 72266-141-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 72266-141-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72266-141-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 72266-141-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 72266-141-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 72266-141-01 557ba5c1ecfa…9c80585c8c6e…
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 A210092-001 AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210092-001 AT
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 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210092-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2020-02-25 a50c72e98297…
Observed Orange Book normalized TE history# 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 .5 mg/mL
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 860805 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 72266-141-01 Azelastine Hydrochloride 1 in 1 CARTON SOLUTION/ DROPS 1 6 72266-141-01 Azelastine Hydrochloride 6 mL in 1 BOTTLE, PLASTIC SOLUTION/ DROPS 6 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72266-141 AZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [FOSUN PHARMA USA INC] 4 Current NDC, Legacy NDC, 2 package rows 20250412_8ae2aec7-329b-41bf-89d5-f189afb782ee.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 · 2 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 72266-141-01 72266014101 1 BOTTLE, PLASTIC in 1 CARTON (72266-141-01) / 6 mL in 1 BOTTLE, PLASTIC 2020-09-08 0000-00-00 No No Current