Home NDC 69452-363 Desloratadine
Product NDC 69452-363
11-digit product format 694520363
Labeler code 69452
Product ID 69452-363_63a77a01-b991-4f03-8f9f-4dd09c8302c4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desloratadine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bionpharma Inc.
Application ANDA078357
Marketing category ANDA
Marketing start 2023-11-28
Substance DESLORATADINE
Active strength 5 mg/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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078357-001 DESLORATADINE DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078357-001 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 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078357-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-02-19 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 Desloratadine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DESLORATADINE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FVF865388R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349420 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 69452-363-20 Desloratadine 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 1 69452-363-30 Desloratadine 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-363 DESLORATADINE TABLET, FILM COATED [BIONPHARMA INC.] 1 Current NDC, 2 package rows 20231128_4d094001-b85a-47b3-bc67-a46660384ece.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 Sample Exclude flag Status 69452-363-20 69452036320 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-363-20) 2023-11-28 No No Current 69452-363-30 69452036330 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-363-30) 2023-11-28 No No Current