Home NDC 62756-523 Desloratadine
Product NDC 62756-523
11-digit product format 627560523
Labeler code 62756
Product ID 62756-523_b5875e34-88ab-4ffc-b9b2-7281ec549566
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desloratadine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA078359
Marketing category ANDA
Marketing start 2010-11-24
Marketing end 0000-00-00
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 2020-12-31
Current FDA listing Historical FDA.report record 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 2 · 114 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A078359-001 DESLORATADINE DESLORATADINE 5MG TABLET / ORAL 2010-11-16
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 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078359-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-11-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078359-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-11-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078359-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-11-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078359-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-11-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078359-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-11-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078359-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-11-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078359-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-11-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078359-001 DESLORATADINE 5MG TABLET / ORAL AB 2010-11-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078359-001 DESLORATADINE 5MG TABLET / ORAL 2010-11-16 e64feba35796…
Observed Orange Book normalized TE history# 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 62756-523-08 Desloratadine 100 in 1 BOTTLE TABLET, FILM COATED 100 8 62756-523-13 Desloratadine 500 in 1 BOTTLE TABLET, FILM COATED 500 8 62756-523-18 Desloratadine 1000 in 1 BOTTLE TABLET, FILM COATED 1000 8 62756-523-83 Desloratadine 30 in 1 BOTTLE TABLET, FILM COATED 30 8 62756-523-88 Desloratadine 100 in 1 BOTTLE TABLET, FILM COATED 100 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DESLORATADINE ACTIVE INGREDIENT FVF865388R DESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 DESLORATADINE ACTIVE MOIETY FVF865388R DESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK DESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W DESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 MEGLUMINE INACTIVE INGREDIENT 6HG8UB2MUY DESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H DESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 DESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI DESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62756-523 DESLORATADINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 8 Legacy NDC, 5 package rows 20190508_58ba2dc8-10c2-4532-92e2-40ec2fee3378.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 62756-523-08 62756052308 100 in 1 BOTTLE Historical 62756-523-13 62756052313 500 in 1 BOTTLE Historical 62756-523-18 62756052318 1000 in 1 BOTTLE Historical 62756-523-83 62756052383 30 in 1 BOTTLE Historical 62756-523-88 62756052388 100 in 1 BOTTLE Historical