Azelastine Hydrochloride

Product NDC: 68071-2497
Requested package NDC: 68071-2497-1
11-digit product format: 680712497
Labeler code: 68071
Product ID: 68071-2497_c922833b-e10e-13a4-e053-2995a90abc88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: azelastine hydrochloride
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA077954
Marketing category: ANDA
Marketing start: 2010-03-01
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: 2022-12-31
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	68071-2497	68071-2497-1	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
A077954-001	AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077954-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077954-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB		2009-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077954-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB		2009-04-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077954-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB		2009-04-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077954-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB		2009-04-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077954-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB		2009-04-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077954-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB		2009-04-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077954-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB		2009-04-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077954-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB		2009-04-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077954-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2009-04-30	`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	A077954-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077954-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077954-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077954-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077954-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077954-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077954-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077954-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077954-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077954-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077954-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077954-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077954-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077954-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077954-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077954-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077954-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077954-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077954-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077954-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077954-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077954-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077954-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077954-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077954-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077954-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077954-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077954-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077954-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077954-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077954-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077954-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077954-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077954-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077954-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077954-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077954-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077954-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077954-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077954-001	AB	1	`e64feba35796…`

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
68071-2497-1	2023-01-30	C162847	48780-1	f386c649-cfbc-0266-e053-dadaa90a7c1a	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 Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2497-1	Azelastine Hydrochloride	1 in 1 CARTON	SPRAY, METERED	1		1
68071-2497-1	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
68071-2497	AZELASTINE HYDROCHLORIDE SPRAY, METERED [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 2 package rows	20210810_c922833b-e10d-13a4-e053-2995a90abc88.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azelastine Hydrochloride	AZELASTINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	a2ba9c1d-b21f-4816-bbe6-949a49e38572	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077954 application number: ANDA077954
Azelastine Hydrochloride	AZELASTINE HYDROCHLORIDE	A-S Medication Solutions	02257284-4bb1-4fe6-8134-e5a67a645114	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077954 application number: ANDA077954
Azelastine Hydrochloride	AZELASTINE HYDROCHLORIDE	Apotex Corp.	4f58c203-f649-a18e-aaf3-70b0797652f4	2025-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077954 application number: ANDA077954
Azelastine Hydrochloride	AZELASTINE HYDROCHLORIDE	Proficient Rx LP	11a74cae-a15b-4a6b-a8c0-1e6a234ee258	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077954 application number: ANDA077954

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	c922833b-e10d-13a4-e053-2995a90abc88	1
1797867	azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal Spray	SCD	c922833b-e10d-13a4-e053-2995a90abc88	1
1797867	azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal Spray	SY	c922833b-e10d-13a4-e053-2995a90abc88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2497-1	68071249701	1 BOTTLE, SPRAY in 1 CARTON (68071-2497-1) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY	2021-08-09	0000-00-00	No	No	Current