Home NDC 51660-753 Loratadine
Product NDC 51660-753
11-digit product format 516600753
Labeler code 51660
Product ID 51660-753_48a60b3d-d011-4d0f-84dc-414c713c76ba
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Ohm Laboratories Inc.
Application ANDA210088
Marketing category ANDA
Marketing start 2018-06-01
Substance LORATADINE
Active strength 5 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210088-001 LORATADINE LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 A210088-002 LORATADINE LORATADINE 10MG TABLET, CHEWABLE / ORAL 2025-04-25
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 · 45 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 2026-02-19 14:30 UTC 2026-02 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210088-002 LORATADINE 10MG TABLET, CHEWABLE / ORAL 2025-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210088-002 LORATADINE 10MG TABLET, CHEWABLE / ORAL 2025-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210088-002 LORATADINE 10MG TABLET, CHEWABLE / ORAL 2025-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 3a93d1ddd44b…
Additional Listing Data#
Finished product Yes
Brand name base Loratadine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LORATADINE 5 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 665078 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 51660-753-31 Loratadine 3 in 1 CARTON TABLET, CHEWABLE 3 4 51660-753-31 Loratadine 10 in 1 BLISTER PACK TABLET, CHEWABLE 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51660-753 LORATADINE TABLET, CHEWABLE [OHM LABORATORIES INC.] 4 Current NDC, Legacy NDC, 2 package rows 20190726_b83de07d-37f4-42b4-b43e-29173454bef0.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 · 38 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 51660-753-31 51660075331 3 BLISTER PACK in 1 CARTON (51660-753-31) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 3 blister pack 2018-06-01 0000-00-00 No No Current