Home NDC 43598-669 levocetirizine dihydrochloride
Product NDC 43598-669
11-digit product format 435980669
Labeler code 43598
Product ID 43598-669_319344e4-2965-c148-d650-3f8cf580a960
Type HUMAN OTC DRUG
Nonproprietary name levocetirizine dihydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Dr. Reddy's Laboratories Inc.
Application ANDA210375
Marketing category ANDA
Marketing start 2018-03-12
Marketing end 2019-12-31
Substance LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength 5 mg/1
NDC exclude flag No
Listing certified through 0000-00-00
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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19
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 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210375-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-01-19 e64feba35796…
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 1 · 16 matching rows.