AZELASTINE hydrochloride nasal solution (nasal spray), 137 mcg

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-11-25
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 6
Source: legacy-cache
Hydrated at: 2026-08-01 20:48:43

Label at a glance#

ProductAZELASTINE HYDROCHLORIDE

Active ingredientAZELASTINE HYDROCHLORIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1313-2

Azelastine Hydrochloride Nasal Spray, 137 mcg per spray

30 mL

Rx only

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

AZELASTINE HYDROCHLORIDE
AZELASTINE
SODIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE
HYPROMELLOSES
EDETATE DISODIUM
CITRIC ACID MONOHYDRATE
BENZALKONIUM CHLORIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1313	70771-1313-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
AZELASTINE HYDROCHLORIDE	0L591QR10I	ACTIB
SODIUM CHLORIDE	451W47IQ8X	IACT
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE	E1W4N241FO	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A091409-001	AZELASTINE HYDROCHLORIDE	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB		2017-08-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091409-001	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 · 44 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
2026-10-15 13:18:30	2026-09	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091409-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091409-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091409-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091409-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091409-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091409-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091409-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091409-001	AZELASTINE HYDROCHLORIDE	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091409-001	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY	SPRAY, METERED / NASAL	AB	2017-08-14	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A091409-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091409-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091409-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091409-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091409-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091409-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091409-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091409-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091409-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091409-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091409-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091409-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091409-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091409-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091409-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091409-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091409-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091409-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091409-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091409-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091409-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091409-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091409-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091409-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091409-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091409-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091409-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091409-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091409-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091409-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091409-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091409-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091409-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091409-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091409-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091409-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091409-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091409-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091409-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091409-001	AB	1	`3a93d1ddd44b…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
449621a3-7bce-4039-95b8-dba8deaaf46b			b8d32cf2-8068-4659-b088-ee51cbf18604	2024-11-25		Exact identifier spl id: 449621a3-7bce-4039-95b8-dba8deaaf46b spl set id: b8d32cf2-8068-4659-b088-ee51cbf18604

Reported adverse events (FAERS/openFDA)#

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