Home NDC 0904-6852-60 Loratadine
Product NDC 0904-6852
Requested package NDC 0904-6852-60
11-digit product format 009046852
Labeler code 0904
Product ID 0904-6852_7c3836c3-7476-49b8-ac03-11718d17c813
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA076301
Marketing category ANDA
Marketing start 2005-02-21
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0904-6852 0904-6852-60 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0904-6852 0904-6852-60 D Discontinued by firm excluded / ndc_excluded.zip 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 A076301-001 LORATADINE LORATADINE 10MG TABLET / ORAL 2004-06-25
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 · 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 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 e64feba35796…
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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-6852 LORATADINE TABLET [MAJOR PHARMACEUTICALS] 8 Current NDC, Legacy NDC, 10 package rows 20250426_dee25423-377b-4b94-a4a8-0dfb8f51aaab.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 3 · 43 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 0904-6852-60 00904685260 1 BOTTLE in 1 CARTON (0904-6852-60) > 100 TABLET in 1 BOTTLE 1 bottle 2018-12-06 0000-00-00 No No Current