Astepro

Product NDC: 0037-0243
11-digit product format: 000370243
Labeler code: 0037
Product ID: 0037-0243_f3358d30-8215-46ac-8ec6-2e13cd303ba2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azelastine Hydrochloride
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Meda Pharmaceuticals
Application: NDA022203
Marketing category: NDA
Marketing start: 2009-10-12
Marketing end: 2020-12-31
Substance: AZELASTINE HYDROCHLORIDE
Active strength: 206 ug/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0037-0243		D	Discontinued by firm	2026-08-17
excluded package	package	0037-0243	0037-0243-04	D	Discontinued by firm	2026-08-17
excluded package	package	0037-0243	0037-0243-30	D	Discontinued by firm	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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0037-0243-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0037-0243-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0037-0243-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0037-0243-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0037-0243-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0037-0243-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0037-0243-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0037-0243-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0037-0243-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0037-0243-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0037-0243-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0037-0243-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0037-0243-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0037-0243-04	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0037-0243-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0037-0243-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0037-0243-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0037-0243-04	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0037-0243-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0037-0243-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0037-0243-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0037-0243-04	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0037-0243-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0037-0243-04	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N022203-001	ASTEPRO	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-10-15
N022203-002	ASTEPRO	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL			2009-08-31

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022203-001	8071073	2028-06-04		Drug product	2011-12-15
N022203-002	8071073	2028-06-04		Drug product	2011-12-15

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 3 · 84 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	N022203-001	ASTEPRO	0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022203-002	ASTEPRO	0.2055MG/SPRAY	SPRAY, METERED / NASAL			2009-08-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022203-001	ASTEPRO	0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022203-002	ASTEPRO	0.2055MG/SPRAY	SPRAY, METERED / NASAL			2009-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022203-001	ASTEPRO	0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022203-002	ASTEPRO	0.2055MG/SPRAY	SPRAY, METERED / NASAL			2009-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022203-001	ASTEPRO	0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-10-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022203-002	ASTEPRO	0.2055MG/SPRAY	SPRAY, METERED / NASAL			2009-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022203-001	ASTEPRO	0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-10-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022203-002	ASTEPRO	0.2055MG/SPRAY	SPRAY, METERED / NASAL			2009-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022203-001	ASTEPRO	0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-10-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022203-002	ASTEPRO	0.2055MG/SPRAY	SPRAY, METERED / NASAL			2009-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022203-001	ASTEPRO	0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-10-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022203-002	ASTEPRO	0.2055MG/SPRAY	SPRAY, METERED / NASAL			2009-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022203-001	ASTEPRO	0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-10-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022203-002	ASTEPRO	0.2055MG/SPRAY	SPRAY, METERED / NASAL			2009-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022203-001	ASTEPRO	0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-10-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022203-002	ASTEPRO	0.2055MG/SPRAY	SPRAY, METERED / NASAL			2009-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022203-001	ASTEPRO	0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-10-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022203-002	ASTEPRO	0.2055MG/SPRAY	SPRAY, METERED / NASAL			2009-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022203-001	ASTEPRO	0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-10-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022203-002	ASTEPRO	0.2055MG/SPRAY	SPRAY, METERED / NASAL			2009-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022203-001	ASTEPRO	0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-10-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022203-002	ASTEPRO	0.2055MG/SPRAY	SPRAY, METERED / NASAL			2009-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022203-001	ASTEPRO	0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-10-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022203-002	ASTEPRO	0.2055MG/SPRAY	SPRAY, METERED / NASAL			2009-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022203-001	ASTEPRO	0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-10-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022203-002	ASTEPRO	0.2055MG/SPRAY	SPRAY, METERED / NASAL			2009-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022203-001	ASTEPRO	0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-10-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022203-002	ASTEPRO	0.2055MG/SPRAY	SPRAY, METERED / NASAL			2009-08-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022203-001	ASTEPRO	0.137MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-10-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022203-002	ASTEPRO	0.2055MG/SPRAY	SPRAY, METERED / NASAL			2009-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022203-001	ASTEPRO	0.137MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-10-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022203-002	ASTEPRO	0.2055MG/SPRAY	SPRAY, METERED / NASAL			2009-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022203-001	ASTEPRO	0.137MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-10-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022203-002	ASTEPRO	0.2055MG/SPRAY	SPRAY, METERED / NASAL			2009-08-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022203-001	ASTEPRO	EQ 0.125MG BASE/SPRAY	SPRAY, METERED / NASAL			2008-10-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022203-002	ASTEPRO	EQ 0.1876MG BASE/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2009-08-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022203-001	ASTEPRO	0.137MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-10-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022203-002	ASTEPRO	0.2055MG/SPRAY	SPRAY, METERED / NASAL			2009-08-31	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022203-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022203-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022203-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022203-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022203-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022203-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022203-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022203-002	AB	1	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 201 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022203-001	8071073	2028-06-04		Drug product	2011-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022203-002	8071073	2028-06-04		Drug product	2011-12-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022203-001	8071073	2028-06-04		Drug product	2011-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022203-002	8071073	2028-06-04		Drug product	2011-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022203-001	8518919	2025-11-22	U-1430		2013-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022203-001	8071073	2028-06-04		Drug product	2011-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022203-002	8518919	2025-11-22	U-1430		2013-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022203-002	9919050	2025-11-22		Drug product	2018-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022203-002	8071073	2028-06-04		Drug product	2011-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022203-001	8518919	2025-11-22	U-1430		2013-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022203-001	8071073	2028-06-04		Drug product	2011-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022203-002	8518919	2025-11-22	U-1430		2013-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022203-002	9919050	2025-11-22		Drug product	2018-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022203-002	8071073	2028-06-04		Drug product	2011-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022203-001	8518919	2025-11-22	U-1430		2013-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022203-001	8071073	2028-06-04		Drug product	2011-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022203-002	8518919	2025-11-22	U-1430		2013-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022203-002	9919050	2025-11-22		Drug product	2018-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022203-002	8071073	2028-06-04		Drug product	2011-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022203-001	8518919	2025-11-22	U-1430		2013-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022203-001	8071073	2028-06-04		Drug product	2011-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022203-002	8518919	2025-11-22	U-1430		2013-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022203-002	9919050	2025-11-22		Drug product	2018-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022203-002	8071073	2028-06-04		Drug product	2011-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022203-001	8518919	2025-11-22	U-1430		2013-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022203-001	8071073	2028-06-04		Drug product	2011-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022203-002	8518919	2025-11-22	U-1430		2013-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022203-002	9919050	2025-11-22		Drug product	2018-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022203-002	8071073	2028-06-04		Drug product	2011-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022203-001	8518919	2025-11-22	U-1430		2013-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022203-001	8071073	2028-06-04		Drug product	2011-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022203-002	8518919	2025-11-22	U-1430		2013-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022203-002	9919050	2025-11-22		Drug product	2018-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022203-002	8071073	2028-06-04		Drug product	2011-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022203-001	8518919	2025-11-22	U-1430		2013-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022203-001	8071073	2028-06-04		Drug product	2011-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022203-002	8518919	2025-11-22	U-1430		2013-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022203-002	9919050	2025-11-22		Drug product	2018-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022203-002	8071073	2028-06-04		Drug product	2011-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022203-001	8518919	2025-11-22	U-1430		2013-09-18	`d8e5a09893c0…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0037-0243-30	ML - Milliliter	0037-0243	1c965fe3-d94a-4da9-be30-686708340e61	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AZELASTINE HYDROCHLORIDE	ACTIVE INGREDIENT	0L591QR10I	ASTEPRO (AZELASTINE HYDROCHLORIDE) SPRAY, METERED [MEDA PHARMACEUTICALS INC.]	16
AZELASTINE	ACTIVE MOIETY	ZQI909440X	ASTEPRO (AZELASTINE HYDROCHLORIDE) SPRAY, METERED [MEDA PHARMACEUTICALS INC.]	16
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	ASTEPRO (AZELASTINE HYDROCHLORIDE) SPRAY, METERED [MEDA PHARMACEUTICALS INC.]	16
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	ASTEPRO (AZELASTINE HYDROCHLORIDE) SPRAY, METERED [MEDA PHARMACEUTICALS INC.]	16
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ASTEPRO (AZELASTINE HYDROCHLORIDE) SPRAY, METERED [MEDA PHARMACEUTICALS INC.]	16
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ASTEPRO (AZELASTINE HYDROCHLORIDE) SPRAY, METERED [MEDA PHARMACEUTICALS INC.]	16
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ASTEPRO (AZELASTINE HYDROCHLORIDE) SPRAY, METERED [MEDA PHARMACEUTICALS INC.]	16
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	ASTEPRO (AZELASTINE HYDROCHLORIDE) SPRAY, METERED [MEDA PHARMACEUTICALS INC.]	16
WATER	INACTIVE INGREDIENT	059QF0KO0R	ASTEPRO (AZELASTINE HYDROCHLORIDE) SPRAY, METERED [MEDA PHARMACEUTICALS INC.]	16