Home NDC 70985-017-01 Loratadine
Product NDC 70985-017
Requested package NDC 70985-017-01
11-digit product format 709850017
Labeler code 70985
Product ID 70985-017_c5c02d48-4206-483d-e053-2995a90a56c1
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET
Route ORAL
Labeler DRUG OCEAN LLC
Application ANDA214684
Marketing category ANDA
Marketing start 2021-06-27
Marketing end 0000-00-00
Substance LORATADINE
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 2022-12-31
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 · 1 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 70985-017 70985-017-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 A214684-001 LORATADINE LORATADINE 10MG TABLET / ORAL 2021-01-07
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.
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 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 a50c72e98297…
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70985-017 LORATADINE TABLET [DRUG OCEAN LLC] 3 Legacy NDC 20231023_bd6cd66b-1144-4d0b-b13a-230590b398e4.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 · 11 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Loratadine LORATADINE NuCare Pharmaceuticals, Inc. 569a35be-d653-181c-e063-6294a90a6eb9 2026-07-14 Warnings Exact identifier application applno (ANDA): 214684 application number: ANDA214684 Loratadine LORATADINE Preferred Pharmaceuticals Inc 0a0d700d-bdba-4c90-a947-5d61d40ce4df 2026-05-28 Warnings Exact identifier application applno (ANDA): 214684 application number: ANDA214684 ValuMeds Allergy Relief Loratadine LORATADINE Cabinet Health P.B.C. 43bc8e38-bd74-411c-b4fe-7d809d24ae46 2026-05-20 Warnings Exact identifier application applno (ANDA): 214684 application number: ANDA214684 Loratadine LORATADINE Strategic Sourcing Services, LLC a527f83a-4ae9-47b1-94e0-7ab3148b025f 2026-01-29 Warnings Exact identifier application applno (ANDA): 214684 application number: ANDA214684 Loratadine LORATADINE Cabinet Health P.B.C. 8b090fa2-9535-456c-b14d-187a2873cdf7 2025-10-27 Warnings Exact identifier application applno (ANDA): 214684 application number: ANDA214684 CVS Loratadine LORATADINE CVS Pharmacy 3d716988-da63-59e6-e063-6394a90a5b4b 2025-10-22 Warnings Exact identifier application applno (ANDA): 214684 application number: ANDA214684 Nuvicare-Allergy Relief Loratadine Tablets, 10 mg LORATADINE NUVICARE LLC 023a46f0-8d1c-4f62-953d-3e6458a54f6e 2025-07-01 Warnings Exact identifier application applno (ANDA): 214684 application number: ANDA214684 Gencare-Allergy Relief Loratadine Tablets, 10 mg LORATADINE Pioneer Life Sciences, LLC 647dc957-4aee-48f6-bb77-e82d3b380e80 2025-06-30 Warnings Exact identifier application applno (ANDA): 214684 application number: ANDA214684 Loratadine LORATADINE Gobrands, Inc 1d182bd6-ad72-4352-b983-407a48c317f0 2025-01-25 Warnings Exact identifier application applno (ANDA): 214684 application number: ANDA214684 Loratadine LORATADINE Advanced Rx Pharmacy of Tennessee, LLC 01cb43cf-57a9-f189-e063-6294a90afd88 2024-12-31 Warnings Exact identifier application applno (ANDA): 214684 application number: ANDA214684 Loratadine LORATADINE Rising Pharmaceuticals, Inc d28128a3-af54-440e-9bd4-0fccf393d18a 2022-03-10 Warnings Exact identifier application applno (ANDA): 214684 application number: ANDA214684
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70985-017-01 70985001701 100 TABLET in 1 PACKAGE (70985-017-01) 100 tablet 2021-06-27 0000-00-00 No No Current