Home NDC 68016-094 Loratadine
Product NDC 68016-094
11-digit product format 680160094
Labeler code 68016
Product ID 68016-094_29355692-7b20-4b38-8611-8a8f86e636a7
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET
Route ORAL
Labeler Chain Drug Consortium, LLC
Application ANDA208314
Marketing category ANDA
Marketing start 2018-04-16
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 A208314-001 LORATADINE LORATADINE 10MG TABLET / ORAL 2018-04-16
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 · 43 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 2026-09-14 22:38:34 2026-08 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 f41ea6bd6efb…
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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-094 LORATADINE TABLET [CHAIN DRUG CONSORTIUM, LLC] 5 Current NDC, Legacy NDC, 8 package rows 20221105_21199958-ac67-4f72-8a8c-4d7d31fa9da4.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 2 of 2 · 21 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 68016-094-10 68016009410 1 BLISTER PACK in 1 CARTON (68016-094-10) / 10 TABLET in 1 BLISTER PACK 1 blister pack 2018-04-16 0000-00-00 No No Current 68016-094-30 68016009430 3 BLISTER PACK in 1 CARTON (68016-094-30) / 10 TABLET in 1 BLISTER PACK 3 blister pack 2018-04-16 0000-00-00 No No Current 68016-094-60 68016009460 1 BOTTLE in 1 CARTON (68016-094-60) / 60 TABLET in 1 BOTTLE 1 bottle 2018-04-16 0000-00-00 No No Current 68016-094-90 68016009490 1 BOTTLE in 1 CARTON (68016-094-90) / 90 TABLET in 1 BOTTLE 1 bottle 2018-04-16 0000-00-00 No No Current