Home NDC 50090-4300 Loratadine
Product NDC 50090-4300
11-digit product format 500904300
Labeler code 50090
Product ID 50090-4300_b7bfdb7b-35b1-4d0c-ad57-3b2f326f2faa
Type HUMAN OTC DRUG
Nonproprietary name Loratadine
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA076301
Marketing category ANDA
Marketing start 2019-02-20
Marketing end 0000-00-00
Substance LORATADINE
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 2020-12-31
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 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 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 · 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 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…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 cb3db0bc1861…
FDA-Initiated Inactive NDC Indexing# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-4300-0 50090430000 10 TABLET in 1 BOTTLE (50090-4300-0) 10 tablet 2019-05-16 0000-00-00 No No Current 50090-4300-1 50090430001 20 TABLET in 1 BOTTLE (50090-4300-1) 20 tablet 2019-05-16 0000-00-00 No No Current 50090-4300-3 50090430003 15 TABLET in 1 BOTTLE (50090-4300-3) 15 tablet 2019-05-16 0000-00-00 No No Current 50090-4300-4 50090430004 30 TABLET in 1 BOTTLE (50090-4300-4) 30 tablet 2019-05-16 0000-00-00 No No Current 50090-4300-5 50090430005 90 TABLET in 1 BOTTLE (50090-4300-5) 90 tablet 2019-05-16 0000-00-00 No No Current 50090-4300-6 50090430006 7 TABLET in 1 BOTTLE (50090-4300-6) 7 tablet 2019-05-16 0000-00-00 No No Current