Home NDC 60505-0147 Loratadine
Product NDC 60505-0147
11-digit product format 605050147
Labeler code 60505
Product ID 60505-0147_c15c5b51-bc6a-e99e-e5e7-52e61c5da7b0
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET
Route ORAL
Labeler Apotex Corp.
Application ANDA076471
Marketing category ANDA
Marketing start 2005-01-24
Substance LORATADINE
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A076471-001 LORATADINE LORATADINE 10MG TABLET / ORAL 2006-02-14
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 · 41 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 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076471-001 LORATADINE 10MG TABLET / ORAL 2006-02-14 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Loratadine
Listing expiration 2026-12-31 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 60505-0147-1 Loratadine 100 in 1 BOTTLE TABLET 100 9 60505-0147-8 Loratadine 1000 in 1 BOTTLE TABLET 1000 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LORATADINE ACTIVE INGREDIENT 7AJO3BO7QN LORATADINE TABLET [BLENHEIM PHARMACAL, INC.] 1 LORATADINE ACTIVE INGREDIENT 7AJO3BO7QN LORATADINE TABLET [APOTEX CORP.] 1 LORATADINE ACTIVE MOIETY 7AJO3BO7QN LORATADINE TABLET [BLENHEIM PHARMACAL, INC.] 1 LORATADINE ACTIVE MOIETY 7AJO3BO7QN LORATADINE TABLET [APOTEX CORP.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LORATADINE TABLET [BLENHEIM PHARMACAL, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LORATADINE TABLET [APOTEX CORP.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 LORATADINE TABLET [BLENHEIM PHARMACAL, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 LORATADINE TABLET [APOTEX CORP.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LORATADINE TABLET [BLENHEIM PHARMACAL, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LORATADINE TABLET [APOTEX CORP.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LORATADINE TABLET [BLENHEIM PHARMACAL, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LORATADINE TABLET [APOTEX CORP.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LORATADINE TABLET [BLENHEIM PHARMACAL, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LORATADINE TABLET [APOTEX CORP.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-0147 LORATADINE TABLET [APOTEX CORP.] 8 Current NDC, Legacy NDC, 2 package rows 20240927_679164cc-7505-7ed4-13fe-87f06cb777d8.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 · 4 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 60505-0147-1 60505014701 100 TABLET in 1 BOTTLE (60505-0147-1) 100 tablet 2005-01-24 2022-06-30 No No Current 60505-0147-8 60505014708 1000 TABLET in 1 BOTTLE (60505-0147-8) 1000 tablet 2005-01-24 0000-00-00 No No Current