Home NDC 0363-5528 levocetirizine dihydrochloride
Product NDC 0363-5528
11-digit product format 003635528
Labeler code 0363
Product ID 0363-5528_8c22b7fd-6c4a-0567-7134-9094bd3522e5
Type HUMAN OTC DRUG
Nonproprietary name levocetirizine dihydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Walgreens Company
Application ANDA210375
Marketing category ANDA
Marketing start 2018-03-12
Marketing end 0000-00-00
Substance LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength 5 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 · 57 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0363-5528-55 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0363-5528-10 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0363-5528-80 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0363-5528-35 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0363-5528-55 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0363-5528-10 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0363-5528-80 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0363-5528-35 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0363-5528-55 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0363-5528-10 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0363-5528-80 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0363-5528-35 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0363-5528-55 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0363-5528-10 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0363-5528-80 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0363-5528-35 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0363-5528-55 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0363-5528-10 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0363-5528-80 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0363-5528-35 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0363-5528-55 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0363-5528-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0363-5528-80 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0363-5528-35 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0363-5528-55 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0363-5528-10 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0363-5528-80 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0363-5528-35 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0363-5528-55 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0363-5528-10 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0363-5528-80 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0363-5528-35 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0363-5528-55 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0363-5528-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0363-5528-80 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0363-5528-35 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0363-5528-55 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0363-5528-10 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0363-5528-80 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0363-5528-35 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0363-5528-55 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0363-5528-10 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0363-5528-80 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0363-5528-35 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0363-5528-55 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0363-5528-10 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0363-5528-80 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0363-5528-35 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…
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# NDC, Effective, Related label table NDC Effective Related label 0363-5528-10 2025-12-10 Levocetirzine Dihydrochloride Tablets USP, 5 mg 0363-5528-35 2025-12-10 Levocetirzine Dihydrochloride Tablets USP, 5 mg 0363-5528-55 2025-12-10 Levocetirzine Dihydrochloride Tablets USP, 5 mg 0363-5528-80 2025-12-10 Levocetirzine Dihydrochloride Tablets USP, 5 mg 0363-5528-10 2025-01-30 Levocetirzine Dihydrochloride Tablets USP, 5 mg 0363-5528-35 2025-01-30 Levocetirzine Dihydrochloride Tablets USP, 5 mg 0363-5528-55 2025-01-30 Levocetirzine Dihydrochloride Tablets USP, 5 mg 0363-5528-80 2025-01-30 Levocetirzine Dihydrochloride Tablets USP, 5 mg
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-5528 LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [WALGREENS COMPANY] 6 Legacy NDC 20231031_acfb0252-28ae-3f02-3657-3517a099054e.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 · 16 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 0363-5528-10 00363552810 2 BLISTER PACK in 1 CARTON (0363-5528-10) > 5 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2018-04-17 0000-00-00 No No Current 0363-5528-35 00363552835 1 BOTTLE in 1 CARTON (0363-5528-35) > 35 TABLET, COATED in 1 BOTTLE 1 bottle 2018-03-12 0000-00-00 No No Current 0363-5528-55 00363552855 1 BOTTLE in 1 CARTON (0363-5528-55) > 55 TABLET, COATED in 1 BOTTLE 1 bottle 2018-03-12 0000-00-00 No No Current 0363-5528-80 00363552880 1 BOTTLE in 1 CARTON (0363-5528-80) > 80 TABLET, COATED in 1 BOTTLE 1 bottle 2018-03-12 0000-00-00 No No Current