Home DailyMed 1c965fe3-d94a-4da9-be30-686708340e61 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:16:10 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 · 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ASTEPRO AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 2008-10-15 N022203-002 ASTEPRO AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED / NASAL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 · 88 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 2026-10-15 13:18:30 2026-09 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 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022203-002 ASTEPRO 0.2055MG/SPRAY SPRAY, METERED / NASAL 2009-08-31 c2088c7a36db…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022203-002 ASTEPRO 0.2055MG/SPRAY SPRAY, METERED / NASAL 2009-08-31 84e616aacf4f…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…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 6 · 205 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N022203-001 8071073 2028-06-04 Drug product 2011-12-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022203-002 8071073 2028-06-04 Drug product 2011-12-15 c2088c7a36db…2026-09-14 22:38:34 2026-08 N022203-001 8071073 2028-06-04 Drug product 2011-12-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022203-002 8071073 2028-06-04 Drug product 2011-12-15 84e616aacf4f…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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.