Home NDC 0280-0065 Astepro Allergy
Product NDC 0280-0065
11-digit product format 002800065
Labeler code 0280
Product ID 0280-0065_452641af-4731-7fc3-e063-6394a90abceb
Type HUMAN OTC DRUG
Nonproprietary name Azelastine HCl
Dosage form SPRAY, METERED
Route NASAL
Labeler Bayer HealthCare LLC.
Application NDA213872
Marketing category NDA
Marketing start 2022-06-27
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 N213872-001 ASTEPRO ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 N213872-002 CHILDREN'S ASTEPRO ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17
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 N213872-001 8071073 2028-06-04 Drug product 2021-07-08 N213872-002 8071073 2028-06-04 Drug product 2021-07-08
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 · 68 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 N213872-001 ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213872-002 CHILDREN'S ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213872-001 ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213872-002 CHILDREN'S ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213872-001 ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213872-002 CHILDREN'S ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213872-001 ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213872-002 CHILDREN'S ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213872-001 ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213872-002 CHILDREN'S ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213872-001 ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213872-002 CHILDREN'S ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213872-001 ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213872-002 CHILDREN'S ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213872-001 ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213872-002 CHILDREN'S ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213872-001 ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213872-002 CHILDREN'S ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213872-001 ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213872-002 CHILDREN'S ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213872-001 ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213872-002 CHILDREN'S ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213872-001 ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213872-002 CHILDREN'S ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213872-001 ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213872-002 CHILDREN'S ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213872-001 ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213872-002 CHILDREN'S ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213872-001 ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N213872-002 CHILDREN'S ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213872-001 ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213872-002 CHILDREN'S ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213872-001 ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N213872-002 CHILDREN'S ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213872-001 ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N213872-002 CHILDREN'S ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213872-001 ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N213872-002 CHILDREN'S ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213872-001 ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N213872-002 CHILDREN'S ASTEPRO ALLERGY 0.2055MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-06-17 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 5 · 192 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 N213872-001 8071073 2028-06-04 Drug product 2021-07-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213872-002 8071073 2028-06-04 Drug product 2021-07-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213872-001 8071073 2028-06-04 Drug product 2021-07-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213872-002 8071073 2028-06-04 Drug product 2021-07-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213872-001 8518919 2025-11-22 U-3166 2021-07-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213872-001 9919050 2025-11-22 Drug product 2021-07-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213872-001 8071073 2028-06-04 Drug product 2021-07-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213872-002 8518919 2025-11-22 U-3166 2021-07-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213872-002 9919050 2025-11-22 Drug product 2021-07-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213872-002 8071073 2028-06-04 Drug product 2021-07-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213872-001 8518919 2025-11-22 U-3166 2021-07-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213872-001 9919050 2025-11-22 Drug product 2021-07-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213872-001 8071073 2028-06-04 Drug product 2021-07-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213872-002 8518919 2025-11-22 U-3166 2021-07-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213872-002 9919050 2025-11-22 Drug product 2021-07-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213872-002 8071073 2028-06-04 Drug product 2021-07-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213872-001 8518919 2025-11-22 U-3166 2021-07-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213872-001 9919050 2025-11-22 Drug product 2021-07-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213872-001 8071073 2028-06-04 Drug product 2021-07-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213872-002 8518919 2025-11-22 U-3166 2021-07-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213872-002 9919050 2025-11-22 Drug product 2021-07-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213872-002 8071073 2028-06-04 Drug product 2021-07-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213872-001 8518919 2025-11-22 U-3166 2021-07-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213872-001 9919050 2025-11-22 Drug product 2021-07-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213872-001 8071073 2028-06-04 Drug product 2021-07-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213872-002 8518919 2025-11-22 U-3166 2021-07-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213872-002 9919050 2025-11-22 Drug product 2021-07-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213872-002 8071073 2028-06-04 Drug product 2021-07-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213872-001 8518919 2025-11-22 U-3166 2021-07-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213872-001 9919050 2025-11-22 Drug product 2021-07-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213872-001 8071073 2028-06-04 Drug product 2021-07-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213872-002 8518919 2025-11-22 U-3166 2021-07-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213872-002 9919050 2025-11-22 Drug product 2021-07-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213872-002 8071073 2028-06-04 Drug product 2021-07-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213872-001 8518919 2025-11-22 U-3166 2021-07-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213872-001 9919050 2025-11-22 Drug product 2021-07-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213872-001 8071073 2028-06-04 Drug product 2021-07-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213872-002 8518919 2025-11-22 U-3166 2021-07-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213872-002 9919050 2025-11-22 Drug product 2021-07-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213872-002 8071073 2028-06-04 Drug product 2021-07-08 2680178bc6a6…
Additional Listing Data#
Finished product Yes
Brand name base Astepro Allergy
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1797883 Internal RxNorm lookup 1797884 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0280-0065-01 Astepro Allergy 1 in 1 CARTON SPRAY, METERED 1 8 0280-0065-01 Astepro Allergy 60 in 1 BOTTLE SPRAY, METERED 60 8 0280-0065-02 Astepro Allergy 120 in 1 BOTTLE SPRAY, METERED 120 8 0280-0065-02 Astepro Allergy 1 in 1 CARTON SPRAY, METERED 1 8 0280-0065-03 Astepro Allergy 120 in 1 BOTTLE SPRAY, METERED 120 8 0280-0065-03 Astepro Allergy 3 in 1 PACKAGE SPRAY, METERED 3 8 0280-0065-04 Astepro Allergy 200 in 1 BOTTLE SPRAY, METERED 200 8 0280-0065-04 Astepro Allergy 1 in 1 CARTON SPRAY, METERED 1 8 0280-0065-05 Astepro Allergy 1 in 1 CARTON SPRAY, METERED 1 8 0280-0065-05 Astepro Allergy 22 in 1 BOTTLE SPRAY, METERED 22 8 0280-0065-09 Astepro Allergy 120 in 1 BOTTLE SPRAY, METERED 120 8 0280-0065-09 Astepro Allergy 2 in 1 CARTON SPRAY, METERED 2 8 0280-0065-10 Astepro Allergy 22 in 1 BOTTLE SPRAY, METERED 22 8 0280-0065-10 Astepro Allergy 1 in 1 CARTON SPRAY, METERED 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-0065 ASTEPRO ALLERGY (AZELASTINE HCL) SPRAY, METERED [BAYER HEALTHCARE LLC.] 7 Current NDC, Legacy NDC, 14 package rows 20241208_e0640846-19a6-7f79-e053-2995a90a8176.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0280-0065-01 00280006501 60 CARTON in 1 BOTTLE (0280-0065-01) / 1 SPRAY, METERED in 1 CARTON 60 carton 2022-07-05 0000-00-00 Yes No Current 0280-0065-02 00280006502 120 CARTON in 1 BOTTLE (0280-0065-02) / 1 SPRAY, METERED in 1 CARTON 120 carton 2022-07-05 0000-00-00 No No Current 0280-0065-03 00280006503 120 PACKAGE in 1 BOTTLE (0280-0065-03) / 3 SPRAY, METERED in 1 PACKAGE 120 package 2022-07-05 0000-00-00 No No Current 0280-0065-04 00280006504 200 CARTON in 1 BOTTLE (0280-0065-04) / 1 SPRAY, METERED in 1 CARTON 200 carton 2022-07-05 0000-00-00 No No Current 0280-0065-05 00280006505 22 CARTON in 1 BOTTLE (0280-0065-05) / 1 SPRAY, METERED in 1 CARTON 22 carton 2023-01-24 Yes No Current 0280-0065-09 00280006509 120 CARTON in 1 BOTTLE (0280-0065-09) / 2 SPRAY, METERED in 1 CARTON 120 carton 2022-07-05 0000-00-00 No No Current 0280-0065-10 00280006510 22 CARTON in 1 BOTTLE (0280-0065-10) / 1 SPRAY, METERED in 1 CARTON 22 carton 2022-07-05 0000-00-00 No No Current