Home NDC 67877-477-50 Azelastine
Product NDC 67877-477
Requested package NDC 67877-477-50
11-digit product format 678770477
Labeler code 67877
Product ID 67877-477_b5281403-77e2-44a3-966f-d9c9efb86453
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Azelastine
Dosage form SPRAY, METERED
Route NASAL
Labeler Ascend Laboratories, LLC
Application ANDA208156
Marketing category ANDA
Marketing start 2017-08-18
Substance AZELASTINE HYDROCHLORIDE
Active strength 137 ug/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 67877-477 67877-477-50 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A208156-001 AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208156-001 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 · 42 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 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208156-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208156-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208156-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208156-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208156-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208156-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208156-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208156-001 AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208156-001 AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY SPRAY, METERED / NASAL AB 2017-08-18 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Azelastine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AZELASTINE HYDROCHLORIDE 137 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 1797867 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67877-477-50 Azelastine 1 in 1 BOTTLE SPRAY, METERED 1 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-477 AZELASTINE SPRAY, METERED [ASCEND LABORATORIES, LLC] 11 Current NDC, Legacy NDC, 1 package rows 20240716_77b20c6b-f30f-42a9-a0ef-d5d0bd3feb56.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 67877-477-50 67877047750 1 SPRAY, METERED in 1 BOTTLE (67877-477-50) 2017-08-18 0000-00-00 No No Current