Home NDC 72162-2308 Desloratadine
Product NDC 72162-2308
11-digit product format 721622308
Labeler code 72162
Product ID 72162-2308_52ff3486-b017-428a-945a-743810c38e51
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desloratadine
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA078355
Marketing category ANDA
Marketing start 2015-06-12
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 A078355-001 DESLORATADINE DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078355-001 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 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078355-001 DESLORATADINE 5MG TABLET / ORAL AB 2012-04-19 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 72162-2308-1 Desloratadine 100 in 1 BOTTLE, PLASTIC TABLET 100 102 72162-2308-3 Desloratadine 30 in 1 BOTTLE, PLASTIC TABLET 30 102 72162-2308-5 Desloratadine 500 in 1 BOTTLE, PLASTIC TABLET 500 102
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72162-2308 DESLORATADINE TABLET [BRYANT RANCH PREPACK] 101 Current NDC, 3 package rows 20240606_cf7f838b-4595-4c81-97b9-e1594347e1bd.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72162-2308-1 72162230801 100 TABLET in 1 BOTTLE, PLASTIC (72162-2308-1) 100 tablet 2024-05-07 No No Current 72162-2308-3 72162230803 30 TABLET in 1 BOTTLE, PLASTIC (72162-2308-3) 30 tablet 2024-05-07 No No Current 72162-2308-5 72162230805 500 TABLET in 1 BOTTLE, PLASTIC (72162-2308-5) 500 tablet 2024-05-07 No No Current