AZELASTINE HYDROCHLORIDE

Product NDC: 69168-478
11-digit product format: 691680478
Labeler code: 69168
Product ID: 69168-478_fc930f5c-a2b9-4e66-814d-ca8d68cc2d29
Type: HUMAN OTC DRUG
Nonproprietary name: AZELASTINE HYDROCHLORIDE
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Allegiant Health
Application: ANDA216421
Marketing category: ANDA
Marketing start: 2025-05-02
Substance: AZELASTINE HYDROCHLORIDE
Active strength: 205.5 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216421-001	AZELASTINE HYDROCHLORIDE ALLERGY	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL			2024-05-29
A216421-002	AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL			2024-05-29

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A216421-001	AZELASTINE HYDROCHLORIDE ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216421-002	AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216421-001	AZELASTINE HYDROCHLORIDE ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216421-002	AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216421-001	AZELASTINE HYDROCHLORIDE ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216421-002	AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216421-001	AZELASTINE HYDROCHLORIDE ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216421-002	AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216421-001	AZELASTINE HYDROCHLORIDE ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216421-002	AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216421-001	AZELASTINE HYDROCHLORIDE ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216421-002	AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216421-001	AZELASTINE HYDROCHLORIDE ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216421-002	AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216421-001	AZELASTINE HYDROCHLORIDE ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216421-002	AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216421-001	AZELASTINE HYDROCHLORIDE ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216421-002	AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216421-001	AZELASTINE HYDROCHLORIDE ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216421-002	AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216421-001	AZELASTINE HYDROCHLORIDE ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216421-002	AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216421-001	AZELASTINE HYDROCHLORIDE ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216421-002	AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216421-001	AZELASTINE HYDROCHLORIDE ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216421-002	AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216421-001	AZELASTINE HYDROCHLORIDE ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216421-002	AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216421-001	AZELASTINE HYDROCHLORIDE ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216421-002	AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	2024-05-29	`a50c72e98297…`

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	205.5 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
1797883	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
3e2fdb0d-c2f5-41ab-b1cd-4fae80648112	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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69168-478-02	AZELASTINE HYDROCHLORIDE	120 in 1 BOTTLE, SPRAY	SPRAY, METERED	120	6
69168-478-02	AZELASTINE HYDROCHLORIDE	2 in 1 CARTON	SPRAY, METERED	2	6
69168-478-63	AZELASTINE HYDROCHLORIDE	120 in 1 BOTTLE, SPRAY	SPRAY, METERED	120	6
69168-478-63	AZELASTINE HYDROCHLORIDE	1 in 1 CARTON	SPRAY, METERED	1	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69168-478	AZELASTINE HYDROCHLORIDE SPRAY, METERED [ALLEGIANT HEALTH]	2	Current NDC, 4 package rows	20250504_3e2fdb0d-c2f5-41ab-b1cd-4fae80648112.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	CVS PHARMACY, INC	22d516d0-da22-4e3b-a4a5-135b009bc968	2026-05-21	Warnings	Exact identifier application applno (ANDA): 216421 application number: ANDA216421
Azelastine Hydrochloride	AZELASTINE HYDROCHLORIDE	Walgreens	ec268981-433f-b26b-4ff0-3a121e0a0d08	2026-04-16	Warnings	Exact identifier application applno (ANDA): 216421 application number: ANDA216421
AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	Allegiant Health	cc7ddac6-95fa-4bc0-824d-f80e404e8d32	2025-05-02	Warnings	Exact identifier application applno (ANDA): 216421 application number: ANDA216421
AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	Allegiant Health	3e2fdb0d-c2f5-41ab-b1cd-4fae80648112	2025-05-02	Warnings	Exact identifier application applno (ANDA): 216421 application number: ANDA216421 ndc (product): 69168-478

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
1797883	azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal Spray	PSN	3e2fdb0d-c2f5-41ab-b1cd-4fae80648112	6
1797883	azelastine hydrochloride 0.206 MG/ACTUAT Metered Dose Nasal Spray	SCD	3e2fdb0d-c2f5-41ab-b1cd-4fae80648112	6
1797883	azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal Spray	SY	3e2fdb0d-c2f5-41ab-b1cd-4fae80648112	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
69168-478-02	69168047802	2 BOTTLE, SPRAY in 1 CARTON (69168-478-02) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY	2025-09-22	No	No	Current
69168-478-63	69168047863	1 BOTTLE, SPRAY in 1 CARTON (69168-478-63) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY	2025-09-22	No	No	Current