Home NDC 47335-938 Azelastine Hydrochloride
Product NDC 47335-938
11-digit product format 473350938
Labeler code 47335
Product ID 47335-938_b2bdb49f-ef3d-467d-aa3b-d7ab72162f4b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azelastine Hydrochloride
Dosage form SOLUTION/ DROPS
Route INTRAOCULAR
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA078738
Marketing category ANDA
Marketing start 2010-05-31
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 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 A078738-001 AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC 2010-06-21
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 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC 2010-06-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC 2010-06-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC 2010-06-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC 2010-06-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC 2010-06-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC 2010-06-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC 2010-06-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC 2010-06-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078738-001 AZELASTINE HYDROCHLORIDE 0.05% SOLUTION/DROPS / OPHTHALMIC AT 2010-06-21 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 .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 47335-938-90 Azelastine Hydrochloride 6 mL in 1 BOTTLE, PLASTIC SOLUTION/ DROPS 6 4 47335-938-90 Azelastine Hydrochloride 1 in 1 BOX SOLUTION/ DROPS 1 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47335-938 AZELASTINE HYDROCHLORIDE SOLUTION/ DROPS [SUN PHARMACEUTICAL INDUSTRIES, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20181024_04e5eede-17ff-4765-af77-d46c139da703.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 47335-938-90 47335093890 1 BOTTLE, PLASTIC in 1 BOX (47335-938-90) / 6 mL in 1 BOTTLE, PLASTIC 2010-05-31 0000-00-00 No No Current