Home NDC 62250-619-08 Desloratadine
Product NDC 62250-619
Requested package NDC 62250-619-08
11-digit product format 622500619
Labeler code 62250
Product ID 62250-619_efd1035a-228c-69c7-e053-2995a90ac3f4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desloratadine
Dosage form TABLET
Route ORAL
Labeler Belcher Pharmaceuticals,LLC
Application ANDA078355
Marketing category ANDA
Marketing start 2012-05-15
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 2023-12-31
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 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 62250-619 62250-619-08 I Inactivated by FDA excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 62250-619 62250-619-08 I Inactivated by FDA excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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.
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 62250-619-01 Desloratadine 30 in 1 BOTTLE TABLET 30 12 62250-619-02 Desloratadine 100 in 1 BOTTLE TABLET 100 12 62250-619-08 Desloratadine 500 in 1 BOTTLE TABLET 500 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DESLORATADINE ACTIVE INGREDIENT FVF865388R DESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC] 3 DESLORATADINE ACTIVE MOIETY FVF865388R DESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 DESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK DESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U DESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC] 3 ZINC STEARATE INACTIVE INGREDIENT H92E6QA4FV DESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62250-619 DESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC] 12 Legacy NDC, 3 package rows 20231006_dbb8e695-f00b-4c67-bd49-09a1ae5bb669.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 62250-619-08 62250061908 500 TABLET in 1 BOTTLE (62250-619-08) 500 tablet 2018-12-28 0000-00-00 No No Current