Azelastine Hydrochloride

Product NDC: 53002-2279
Requested package NDC: 53002-2279-1
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53002-2279	53002-2279-1	I	Inactivated by FDA		2026-08-17

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`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-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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090423-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090423-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090423-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090423-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090423-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090423-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090423-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090423-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090423-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090423-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090423-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090423-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090423-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090423-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090423-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090423-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090423-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090423-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090423-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090423-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090423-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090423-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090423-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090423-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090423-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090423-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090423-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090423-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090423-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090423-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090423-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090423-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090423-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33	Product name	3	20260126
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
85ee67c3-6973-4172-9ada-b124d28b42f8	Product name	5	20210528
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
6397aa5d-11e2-42ce-b46f-ac49599ccf00	Product name	5	20201006
033d5d5b-187f-1f40-1e5a-11d732813f92	Product name	4	20200626
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53002-2279-1	2024-01-30	C162847	48780-1	1030e365-00eb-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use AZELASTINE HYDROCHLORIDE NASAL SOLUTION safely and effectively. See full prescribing information for AZELASTINE HYDROCHLORIDE NASAL SOLUTION. AZELASTINE HYDROCHLORIDE nasal solution (nasal spray) Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53002-2279-1	Azelastine Hydrochloride	1 in 1 BOX	SPRAY, METERED	1		1
53002-2279-1	Azelastine Hydrochloride	200 in 1 BOTTLE, SPRAY	SPRAY, METERED	200		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-2279	AZELASTINE HYDROCHLORIDE SPRAY, METERED [RPK PHARMACEUTICALS, INC.]	1	Legacy NDC, 2 package rows	20220331_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azelastine Hydrochloride	AZELASTINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	305c6dc8-8247-473d-9975-b02903af6d53	2018-12-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090423 application number: ANDA090423

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0L591QR10I	AZELASTINE HYDROCHLORIDE	79307-93-0	AZELASTINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1797867	azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal Spray	PSN	2ffdc506-c432-405c-91d5-0cabe7bcbf86	1
1797867	azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal Spray	SCD	2ffdc506-c432-405c-91d5-0cabe7bcbf86	1
1797867	azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal Spray	SY	2ffdc506-c432-405c-91d5-0cabe7bcbf86	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-2279-1	53002227901	1 BOTTLE, SPRAY in 1 BOX (53002-2279-1) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY	2021-01-01	0000-00-00	No	No	Current