Home NDC 68071-5308-3 Loratadine
Product NDC 68071-5308
Requested package NDC 68071-5308-3
11-digit product format 680715308
Labeler code 68071
Product ID 68071-5308_569a35be-d654-181c-e063-6294a90a6eb9
Type HUMAN OTC DRUG
Nonproprietary name loratadine
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals, Inc.
Application ANDA214684
Marketing category ANDA
Marketing start 2022-03-10
Substance LORATADINE
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 2026-09-14 22:38:34 2026-08 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214684-001 LORATADINE 10MG TABLET / ORAL 2021-01-07 caaa826d4ba7…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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Loratadine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LORATADINE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7AJO3BO7QN Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311372 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 ndc (package): 68071-5308-3 ndc (product): 68071-5308 ndc11 (package): 68071530803 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 Sample Exclude flag Status 68071-5308-3 68071530803 30 TABLET in 1 BOTTLE (68071-5308-3) 30 tablet 2026-07-14 No No Current