Azelastine Hydrochloride

Product NDC: 65162-676
11-digit product format: 651620676
Labeler code: 65162
Product ID: 65162-676_0ead3061-d60d-4911-91cc-489d3b5fe573
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azelastine
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA204660
Marketing category: ANDA
Marketing start: 2017-09-05
Substance: AZELASTINE HYDROCHLORIDE
Active strength: 1 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

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	65162-676		I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	65162-676	65162-676-84	I	Inactivated by FDA		excluded / ndc_excluded.zip	`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
A204660-001	AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB		2017-08-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A204660-001	AB

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	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204660-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204660-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204660-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204660-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204660-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204660-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204660-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204660-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204660-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-28	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204660-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204660-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204660-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204660-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204660-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204660-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204660-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204660-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204660-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204660-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204660-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204660-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204660-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204660-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204660-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204660-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204660-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204660-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204660-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204660-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204660-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204660-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204660-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204660-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204660-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204660-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204660-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204660-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204660-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204660-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204660-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204660-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204660-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204660-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204660-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204660-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204660-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204660-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204660-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204660-001	AB	1	`e64feba35796…`

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	1 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
1797867	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7902605c-944a-4d7e-a7d4-eb4a71bcacdb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33	Product name	3	20260126
85ee67c3-6973-4172-9ada-b124d28b42f8	Product name	5	20210528
6397aa5d-11e2-42ce-b46f-ac49599ccf00	Product name	5	20201006
033d5d5b-187f-1f40-1e5a-11d732813f92	Product name	4	20200626

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65162-676-84	2024-03-11	C162847	48780-1	1030e365-5709-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use AZELASTINE HYDROCHLORIDE NASAL SPRAY safely and effectively. See full prescribing information for AZELASTINE HYDROCHLORIDE NASAL SPRAY. AZELASTINE HYDROCHLORIDE nasal spray, for intranasal use Initial U.S. Approval: 1996
65162-676-84	2024-01-30	C162847	48780-1	1030e365-5709-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use AZELASTINE HYDROCHLORIDE NASAL SPRAY safely and effectively. See full prescribing information for AZELASTINE HYDROCHLORIDE NASAL SPRAY. AZELASTINE HYDROCHLORIDE nasal spray, for intranasal use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65162-676-84	Azelastine Hydrochloride	30 mL in 1 BOTTLE, SPRAY	SPRAY, METERED	30		12
65162-676-84	Azelastine Hydrochloride	1 in 1 CARTON	SPRAY, METERED	1		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-676-84	ML - Milliliter	65162-676	8ef5a624-adb7-4755-ae9f-63835bf24f8f	1	2017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-676	AZELASTINE HYDROCHLORIDE (AZELASTINE) SPRAY, METERED [AMNEAL PHARMACEUTICALS LLC]	12	Current NDC, Legacy NDC, 2 package rows	20240312_7902605c-944a-4d7e-a7d4-eb4a71bcacdb.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azelastine Hydrochloride	AZELASTINE	AvKARE	bca75501-4140-4d77-e053-2a95a90a019f	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204660 application number: ANDA204660
Azelastine Hydrochloride	AZELASTINE	Amneal Pharmaceuticals LLC	7902605c-944a-4d7e-a7d4-eb4a71bcacdb	2018-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204660 application number: ANDA204660 ndc (product): 65162-676

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0L591QR10I	AZELASTINE HYDROCHLORIDE	79307-93-0	AZELASTINE HYDROCHLORIDE
ZQI909440X	AZELASTINE	58581-89-8	Azelastine

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	7902605c-944a-4d7e-a7d4-eb4a71bcacdb	12
1797867	azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal Spray	SCD	7902605c-944a-4d7e-a7d4-eb4a71bcacdb	12
1797867	azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal Spray	SY	7902605c-944a-4d7e-a7d4-eb4a71bcacdb	12
1797867	azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal Spray	PSN	a710e553-9ce8-4c92-a186-1649ec10b88d	5
1797867	azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal Spray	SCD	a710e553-9ce8-4c92-a186-1649ec10b88d	5
1797867	azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal Spray	SY	a710e553-9ce8-4c92-a186-1649ec10b88d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-676-84	65162067684	1 BOTTLE, SPRAY in 1 CARTON (65162-676-84) / 30 mL in 1 BOTTLE, SPRAY	2017-09-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Azelastine Hydrochloride	A-S Medication Solutions	2021-04-16	HUMAN PRESCRIPTION DRUG LABEL	5
Azelastine Hydrochloride	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals, LLC	2018-10-18	HUMAN PRESCRIPTION DRUG LABEL	12