Home NDC 68016-055 Allergy Relief
Product NDC 68016-055
11-digit product format 680160055
Labeler code 68016
Product ID 68016-055_af0f9bd2-3b77-967a-e053-2995a90a9f6a
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler CHAIN DRUG CONSORTIUM
Application ANDA206214
Marketing category ANDA
Marketing start 2018-12-01
Marketing end 0000-00-00
Substance LORATADINE
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 2021-12-31
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68016-055-10 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68016-055-10 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A206214-001 LORATADINE LORATADINE 10MG CAPSULE / ORAL 2016-09-23
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.
Product history page 1 of 2 · 42 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 2026-08-18 06:07:40 2026-07 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206214-001 LORATADINE 10MG CAPSULE / ORAL 2016-09-23 e64feba35796…
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-055 ALLERGY RELIEF (LORATADINE) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM] 3 Legacy NDC 20241013_c63bbb89-9125-42da-b652-36c32b839df3.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 · 10 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 68016-055-10 68016005510 1 BLISTER PACK in 1 CARTON (68016-055-10) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 1 blister pack 2018-12-01 0000-00-00 No No Current