Home NDC 68071-3596-6 Loratadine
Product NDC 68071-3596
Requested package NDC 68071-3596-6
11-digit product format 680713596
Labeler code 68071
Product ID 68071-3596_4ece9297-a72e-a420-e063-6394a90ab367
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA210722
Marketing category ANDA
Marketing start 2020-01-01
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 A210722-001 LORATADINE LORATADINE 10MG TABLET / ORAL 2019-12-23
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 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210722-001 LORATADINE 10MG TABLET / ORAL 2019-12-23 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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-3596-3 Loratadine 30 in 1 BOTTLE TABLET 30 3 68071-3596-6 Loratadine 60 in 1 BOTTLE TABLET 60 3 68071-3596-9 Loratadine 90 in 1 BOTTLE TABLET 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-3596 LORATADINE TABLET [NUCARE PHARMACEUTICALS,INC.] 2 Current NDC, 3 package rows 20240820_16f00a3a-0777-f70c-e063-6294a90a71c9.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 · 40 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68071-3596-6 68071359606 60 TABLET in 1 BOTTLE (68071-3596-6) 60 tablet 2024-04-25 No No Current