Home NDC 69543-107 Desloratadine
Product NDC 69543-107
11-digit product format 695430107
Labeler code 69543
Product ID 69543-107_7c658c72-2694-49dd-9950-0aed03e3d7dc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desloratadine
Dosage form TABLET
Route ORAL
Labeler Virtus Pharmaceuticals, LLC
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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 69543-107-10 Desloratadine 100 in 1 BOTTLE, PLASTIC TABLET 100 7 69543-107-30 Desloratadine 30 in 1 BOTTLE, PLASTIC TABLET 30 7 69543-107-50 Desloratadine 500 in 1 BOTTLE, PLASTIC TABLET 500 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Desloratadine ACTIVE INGREDIENT FVF865388R DESLORATADINE TABLET [VIRTUS PHARMACEUTICALS] 2 Desloratadine ACTIVE MOIETY FVF865388R DESLORATADINE TABLET [VIRTUS PHARMACEUTICALS] 2 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U DESLORATADINE TABLET [VIRTUS PHARMACEUTICALS] 2 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 DESLORATADINE TABLET [VIRTUS PHARMACEUTICALS] 2 FD&C blue no. 2 INACTIVE INGREDIENT L06K8R7DQK DESLORATADINE TABLET [VIRTUS PHARMACEUTICALS] 2 Starch, Corn INACTIVE INGREDIENT O8232NY3SJ DESLORATADINE TABLET [VIRTUS PHARMACEUTICALS] 2 talc INACTIVE INGREDIENT 7SEV7J4R1U DESLORATADINE TABLET [VIRTUS PHARMACEUTICALS] 2 zinc stearate INACTIVE INGREDIENT H92E6QA4FV DESLORATADINE TABLET [VIRTUS PHARMACEUTICALS] 2 DESLORATADINE ACTIVE INGREDIENT FVF865388R DESLORATADINE TABLET [AVKARE, INC.] 1 DESLORATADINE ACTIVE MOIETY FVF865388R DESLORATADINE TABLET [AVKARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DESLORATADINE TABLET [AVKARE, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 DESLORATADINE TABLET [AVKARE, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK DESLORATADINE TABLET [AVKARE, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DESLORATADINE TABLET [AVKARE, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U DESLORATADINE TABLET [AVKARE, INC.] 1 ZINC STEARATE INACTIVE INGREDIENT H92E6QA4FV DESLORATADINE TABLET [AVKARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69543-107 DESLORATADINE TABLET [VIRTUS PHARMACEUTICALS] 6 Current NDC, Legacy NDC, 3 package rows 20210410_0fe374d0-c14b-4102-b568-eb79165fc7ef.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 Marketing end Sample Exclude flag Status 69543-107-10 69543010710 100 TABLET in 1 BOTTLE, PLASTIC (69543-107-10) 100 tablet 2015-06-12 0000-00-00 No No Current 69543-107-30 69543010730 30 in 1 BOTTLE, PLASTIC Historical 69543-107-50 69543010750 500 TABLET in 1 BOTTLE, PLASTIC (69543-107-50) 500 tablet 2015-06-12 0000-00-00 No No Current