Home NDC 68788-7769 Allergy Relief
Product NDC 68788-7769
11-digit product format 687887769
Labeler code 68788
Product ID 68788-7769_66a54c73-3f3a-4332-9e11-a95fcc175d24
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET
Route ORAL
Labeler Preferred Pharmaceuticals, Inc.
Application ANDA075209
Marketing category ANDA
Marketing start 2020-08-03
Marketing end 0000-00-00
Substance LORATADINE
Active strength 10 mg/1
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 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68788-7769-0 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68788-7769-0 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68788-7769-0 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68788-7769-0 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68788-7769-0 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68788-7769-0 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68788-7769-0 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68788-7769-0 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68788-7769-1 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68788-7769-3 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68788-7769-9 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68788-7769-5 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68788-7769-0 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 A075209-001 LORATADINE LORATADINE 10MG TABLET / ORAL 2003-01-21
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 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 cb3db0bc1861…
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-7769 ALLERGY RELIEF NON DROWSY (LORATADINE) TABLET [PREFERRED PHARMACEUTICALS, INC.] 5 Legacy NDC 20250112_9a5ffe75-cfde-4164-b5ad-398a9e68754d.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 2 · 24 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68788-7769-0 68788776900 10 TABLET in 1 BOTTLE, PLASTIC (68788-7769-0) 10 tablet 2020-08-03 0000-00-00 No No Current 68788-7769-1 68788776901 14 TABLET in 1 BOTTLE, PLASTIC (68788-7769-1) 14 tablet 2020-08-03 0000-00-00 No No Current 68788-7769-3 68788776903 30 TABLET in 1 BOTTLE, PLASTIC (68788-7769-3) 30 tablet 2020-08-03 0000-00-00 No No Current 68788-7769-5 68788776905 15 TABLET in 1 BOTTLE, PLASTIC (68788-7769-5) 15 tablet 2020-08-03 0000-00-00 No No Current 68788-7769-9 68788776909 90 TABLET in 1 BOTTLE, PLASTIC (68788-7769-9) 90 tablet 2020-08-03 0000-00-00 No No Current