Azelastine Hydrochloride

Product NDC: 60505-0833
11-digit product format: 605050833
Labeler code: 60505
Product ID: 60505-0833_6ace9d74-df2e-8b53-9bc8-72a794f3a21a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: azelastine hydrochloride
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Apotex Corp.
Application: ANDA077954
Marketing category: ANDA
Marketing start: 2010-03-01
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: 2026-12-31
Current FDA listing: Yes

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…`

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	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
4f58c203-f649-a18e-aaf3-70b0797652f4	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
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
033d5d5b-187f-1f40-1e5a-11d732813f92	Product name	4	20200626
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60505-0833-5	Azelastine Hydrochloride	1 in 1 CARTON	SPRAY, METERED	1		13
60505-0833-5	Azelastine Hydrochloride	200 in 1 BOTTLE, SPRAY	SPRAY, METERED	200		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-0833-5	ML - Milliliter	60505-0833	8a8f4a0e-d9cf-42cf-899c-28a38531a8b3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AZELASTINE HYDROCHLORIDE	ACTIVE INGREDIENT	0L591QR10I	AZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ]	4
AZELASTINE	ACTIVE MOIETY	ZQI909440X	AZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ]	4
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	AZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	AZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	AZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	AZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ]	4
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	AZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	AZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ]	4
azelastine hydrochloride	ACTIVE INGREDIENT	0L591QR10I	AZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]	1
azelastine	ACTIVE MOIETY	ZQI909440X	AZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	AZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	AZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	AZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	AZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	AZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	AZELASTINE HYDROCHLORIDE SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-0833	AZELASTINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP. ]	12	Current NDC, Legacy NDC, 2 package rows	20240920_4f58c203-f649-a18e-aaf3-70b0797652f4.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 ndc (product): 60505-0833
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	02257284-4bb1-4fe6-8134-e5a67a645114	18
1797867	azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal Spray	SCD	02257284-4bb1-4fe6-8134-e5a67a645114	18
1797867	azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal Spray	SY	02257284-4bb1-4fe6-8134-e5a67a645114	18
1797867	azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal Spray	PSN	4f58c203-f649-a18e-aaf3-70b0797652f4	13
1797867	azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal Spray	SCD	4f58c203-f649-a18e-aaf3-70b0797652f4	13
1797867	azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal Spray	SY	4f58c203-f649-a18e-aaf3-70b0797652f4	13
1797867	azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal Spray	PSN	11a74cae-a15b-4a6b-a8c0-1e6a234ee258	4
1797867	azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal Spray	SCD	11a74cae-a15b-4a6b-a8c0-1e6a234ee258	4
1797867	azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal Spray	SY	11a74cae-a15b-4a6b-a8c0-1e6a234ee258	4
1797867	azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal Spray	PSN	06ac404a-aa75-413d-b85b-d5e07b1b82cd	3
1797867	azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal Spray	SCD	06ac404a-aa75-413d-b85b-d5e07b1b82cd	3
1797867	azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal Spray	SY	06ac404a-aa75-413d-b85b-d5e07b1b82cd	3
1797867	azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal Spray	PSN	666f0e35-577d-4ebf-b3ed-3660725f8277	1
1797867	azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal Spray	PSN	c922833b-e10d-13a4-e053-2995a90abc88	1
1797867	azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal Spray	PSN	a2ba9c1d-b21f-4816-bbe6-949a49e38572	1
1797867	azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal Spray	SCD	666f0e35-577d-4ebf-b3ed-3660725f8277	1
1797867	azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal Spray	SCD	a2ba9c1d-b21f-4816-bbe6-949a49e38572	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
1797867	azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal Spray	SY	a2ba9c1d-b21f-4816-bbe6-949a49e38572	1
1797867	azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal Spray	SY	666f0e35-577d-4ebf-b3ed-3660725f8277	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-0833-5	60505083305	1 BOTTLE, SPRAY in 1 CARTON (60505-0833-5) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY	2010-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Azelastine Hydrochloride	Preferred Pharmaceuticals Inc.	2025-11-17	HUMAN PRESCRIPTION DRUG LABEL	1
Azelastine Hydrochloride	A-S Medication Solutions	2025-11-06	HUMAN PRESCRIPTION DRUG LABEL	18
Azelastine Hydrochloride	Apotex Corp.	2025-09-16	HUMAN PRESCRIPTION DRUG LABEL	13
Azelastine Hydrochloride	Proficient Rx LP	2023-10-01	HUMAN PRESCRIPTION DRUG LABEL	4
Azelastine Hydrochloride	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	3
Azelastine Hydrochloride	NuCare Pharmaceuticals,Inc.	2021-08-09	HUMAN PRESCRIPTION DRUG LABEL	1
A zelastine Hydrochloride Nasal Solution 0.1% (Nasal Spray), 137 mcg/spray For Intranasal Use Only	Physicians Total Care, Inc.	2010-02-25	Human prescription drug label	1