Azelastine Hydrochloride

Product NDC
53002-2279
11-digit product format
530022279
Labeler code
53002
Product ID
53002-2279_0aa49847-53d6-4cea-904f-535a315a4b59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azelastine Hydrochloride
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA090423
Marketing category
ANDA
Marketing start
2012-05-24
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53002-2279IInactivated by FDA2026-08-17
excluded packagepackage53002-227953002-2279-1IInactivated by FDA2026-08-17

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 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53002-2279-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53002-2279-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53002-2279-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53002-2279-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53002-2279-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53002-2279-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-2279-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-2279-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-2279-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53002-2279-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53002-2279-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53002-2279-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53002-2279-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53002-2279-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53002-2279-11332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090423-001AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASAL2012-05-23

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASAL2012-05-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASAL2012-05-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASAL2012-05-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASAL2012-05-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASAL2012-05-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASAL2012-05-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASAL2012-05-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASAL2012-05-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASALAB2012-05-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASALAB2012-05-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASALAB2012-05-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASALAB2012-05-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASALAB2012-05-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASALAB2012-05-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASALAB2012-05-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASALAB2012-05-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASALAB2012-05-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASALAB2012-05-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090423-001AZELASTINE HYDROCHLORIDEEQ 0.125MG BASE/SPRAYSPRAY, METERED / NASALAB2012-05-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASALAB2012-05-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASALAB2012-05-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090423-001AZELASTINE HYDROCHLORIDEEQ 0.125MG BASE/SPRAYSPRAY, METERED / NASALAB2012-05-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A090423-001AZELASTINE HYDROCHLORIDEEQ 0.125MG BASE/SPRAYSPRAY, METERED / NASALAB2012-05-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090423-001AZELASTINE HYDROCHLORIDEEQ 0.125MG BASE/SPRAYSPRAY, METERED / NASALAB2012-05-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090423-001AZELASTINE HYDROCHLORIDEEQ 0.125MG BASE/SPRAYSPRAY, METERED / NASALAB2012-05-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090423-001AZELASTINE HYDROCHLORIDEEQ 0.125MG BASE/SPRAYSPRAY, METERED / NASALAB2012-05-233f01610625f2…
2019-09-15 20:21 UTC2019-09A090423-001AZELASTINE HYDROCHLORIDEEQ 0.125MG BASE/SPRAYSPRAY, METERED / NASALAB2012-05-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A090423-001AZELASTINE HYDROCHLORIDEEQ 0.125MG BASE/SPRAYSPRAY, METERED / NASALAB2012-05-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASALAB2012-05-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASALAB2012-05-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASALAB2012-05-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASALAB2012-05-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASALAB2012-05-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASALAB2012-05-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASALAB2012-05-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASALAB2012-05-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASALAB2012-05-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASALAB2012-05-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASALAB2012-05-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090423-001AZELASTINE HYDROCHLORIDE0.137MG/SPRAYSPRAY, METERED / NASALAB2012-05-23e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090423-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090423-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090423-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090423-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090423-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090423-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090423-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090423-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090423-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090423-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090423-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090423-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090423-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090423-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090423-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090423-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090423-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090423-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090423-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090423-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090423-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090423-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090423-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090423-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090423-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090423-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090423-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090423-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090423-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090423-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090423-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090423-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090423-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33Product name320260126
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
85ee67c3-6973-4172-9ada-b124d28b42f8Product name520210528
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
6397aa5d-11e2-42ce-b46f-ac49599ccf00Product name520201006
033d5d5b-187f-1f40-1e5a-11d732813f92Product name420200626
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2279-1Azelastine Hydrochloride1 in 1 BOXSPRAY, METERED11
53002-2279-1Azelastine Hydrochloride200 in 1 BOTTLE, SPRAYSPRAY, METERED2001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2279AZELASTINE HYDROCHLORIDE SPRAY, METERED [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 2 package rows20220331_2ffdc506-c432-405c-91d5-0cabe7bcbf86.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Azelastine HydrochlorideAZELASTINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.305c6dc8-8247-473d-9975-b02903af6d532018-12-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090423
application number: ANDA090423

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797867azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal SprayPSN2ffdc506-c432-405c-91d5-0cabe7bcbf861
1797867azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal SpraySCD2ffdc506-c432-405c-91d5-0cabe7bcbf861
1797867azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal SpraySY2ffdc506-c432-405c-91d5-0cabe7bcbf861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-2279-1530022279011 BOTTLE, SPRAY in 1 BOX (53002-2279-1) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY2021-01-010000-00-00NoNoCurrent