AZELASTINE HYDROCHLORIDE

Product NDC: 68788-8514
Requested package NDC: 68788-8514-2
11-digit product format: 687888514
Labeler code: 68788
Product ID: 68788-8514_9bc32bee-67cc-4e7c-a128-185235edc8c6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AZELASTINE HYDROCHLORIDE
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA212289
Marketing category: ANDA
Marketing start: 2023-09-01
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A212289-001	AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB		2020-05-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212289-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212289-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212289-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212289-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212289-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212289-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-05-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212289-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212289-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212289-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212289-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212289-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212289-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212289-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212289-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212289-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212289-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212289-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212289-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212289-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212289-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212289-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212289-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212289-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212289-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212289-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212289-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212289-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212289-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212289-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212289-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212289-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212289-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212289-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212289-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212289-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212289-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212289-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212289-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212289-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212289-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212289-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212289-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212289-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212289-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212289-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: AZELASTINE HYDROCHLORIDE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AZELASTINE HYDROCHLORIDE	137 ug/1

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
37c40f8d-269c-4df8-8ac7-cbe78f4ca5c4	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-8514-2	AZELASTINE HYDROCHLORIDE	200 in 1 BOTTLE, SPRAY	SPRAY, METERED	200		4
68788-8514-2	AZELASTINE HYDROCHLORIDE	1 in 1 CARTON	SPRAY, METERED	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8514	AZELASTINE HYDROCHLORIDE SPRAY, METERED [PREFERRED PHARMACEUTICALS INC.]	3	Current NDC, 2 package rows	20250207_37c40f8d-269c-4df8-8ac7-cbe78f4ca5c4.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.	37c40f8d-269c-4df8-8ac7-cbe78f4ca5c4	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212289 application number: ANDA212289 ndc (package): 68788-8514-2 ndc (product): 68788-8514 ndc11 (package): 68788851402
AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	NorthStar Rx LLC	cb0aca6d-ff9c-4239-8681-d212a6764ba9	2025-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212289 application number: ANDA212289
AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	A-S Medication Solutions	fc9d031d-428d-4d53-8e63-feb96d5ab01a	2024-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212289 application number: ANDA212289
AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	Aurobindo Pharma Limited	97c91a09-98d0-4666-8448-0bd50c02bb14	2024-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212289 application number: ANDA212289

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	37c40f8d-269c-4df8-8ac7-cbe78f4ca5c4	4
1797867	azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal Spray	SCD	37c40f8d-269c-4df8-8ac7-cbe78f4ca5c4	4
1797867	azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal Spray	SY	37c40f8d-269c-4df8-8ac7-cbe78f4ca5c4	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68788-8514-2	68788851402	1 BOTTLE, SPRAY in 1 CARTON (68788-8514-2) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY	2023-09-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AZELASTINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	2026-03-11	HUMAN PRESCRIPTION DRUG LABEL	4