Home NDC 85766-117 MEDIQUE Loradamed
Product NDC 85766-117
11-digit product format 857660117
Labeler code 85766
Product ID 85766-117_50322360-43ae-7232-e063-6394a90ae5f8
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sportpharm LLC
Application ANDA076134
Marketing category ANDA
Marketing start 2008-12-30
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 A076134-001 LORATADINE LORATADINE 10MG TABLET / ORAL 2003-08-18
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 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076134-001 LORATADINE 10MG TABLET / ORAL 2003-08-18 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 MEDIQUE Loradamed
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311372 Internal RxNorm lookup 1020126 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 85766-117-12 MEDIQUE Loradamed 10 in 1 BOX TABLET, FILM COATED 10 2 85766-117-46 MEDIQUE Loradamed 1 in 1 PACKET TABLET, FILM COATED 1 2 85766-117-50 MEDIQUE Loradamed 50 in 1 BOX TABLET, FILM COATED 50 2
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 · 25 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 85766-117-12 85766011712 10 PACKET in 1 BOX (85766-117-12) / 1 TABLET, FILM COATED in 1 PACKET (85766-117-46) 10 packet 2025-12-02 No No Current 85766-117-46 85766011746 1 TABLET, FILM COATED in 1 PACKET (85766-117-46) 2025-12-02 No No Current 85766-117-50 85766011750 50 PACKET in 1 BOX (85766-117-50) / 1 TABLET, FILM COATED in 1 PACKET (85766-117-46) 50 packet 2025-12-02 No No Current