Home NDC 78206-119 Clarinex
Product NDC 78206-119
11-digit product format 782060119
Labeler code 78206
Product ID 78206-119_6ec783d3-9308-4f6b-bfda-b41888b95102
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desloratadine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Organon LLC
Application NDA021165
Marketing category NDA
Marketing start 2021-06-01
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 1 .
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 N021165-001 CLARINEX DESLORATADINE 5MG TABLET / ORAL AB RLD, RS 2001-12-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021165-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021165-001 CLARINEX 5MG TABLET / ORAL AB RLD, RS 2001-12-21 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021165-001 6100274 2019-07-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021165-001 7405223 2019-07-07 U-886 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021165-001 6100274*PED 2020-01-07 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021165-001 7405223*PED 2020-01-07 Pediatric extension 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N021165-001 6100274*PED 2020-01-07 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021165-001 7405223*PED 2020-01-07 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021165-001 6100274*PED 2020-01-07 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021165-001 7405223*PED 2020-01-07 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021165-001 6100274 2019-07-07 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021165-001 7405223 2019-07-07 U-886 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021165-001 6100274*PED 2020-01-07 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021165-001 7405223*PED 2020-01-07 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021165-001 6100274 2019-07-07 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021165-001 7405223 2019-07-07 U-886 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021165-001 6100274*PED 2020-01-07 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021165-001 7405223*PED 2020-01-07 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021165-001 6100274 2019-07-07 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021165-001 7405223 2019-07-07 U-886 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021165-001 6100274*PED 2020-01-07 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021165-001 7405223*PED 2020-01-07 Pediatric extension ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base Clarinex
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349420 Internal RxNorm lookup 352086 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 78206-119-01 Clarinex 100 in 1 BOTTLE TABLET, FILM COATED 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78206-119 CLARINEX (DESLORATADINE) TABLET, FILM COATED [ORGANON LLC] 6 Current NDC, Legacy NDC, 1 package rows 20250528_c671342e-69a2-4ca5-abc2-8166ed4240d4.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 78206-119-01 78206011901 100 TABLET, FILM COATED in 1 BOTTLE (78206-119-01) 2021-06-01 0000-00-00 No No Current