Home NDC 82725-4051-1 Goodmeds Levocetirizine Dihydrochloride 5mg 365 count
Product NDC 82725-4051
Requested package NDC 82725-4051-1
11-digit product format 827254051
Labeler code 82725
Product ID 82725-4051_5cb46662-78a0-9d8a-e063-6294a90a8b84
Type HUMAN OTC DRUG
Nonproprietary name Levocetirizine Dihydrochloride 5mg
Dosage form TABLET
Route ORAL
Labeler Cabinet Health P.B.C.
Application ANDA213513
Marketing category ANDA
Marketing start 2026-06-30
Substance LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29
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.
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 2026-09-14 22:38:34 2026-08 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213513-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2020-04-29 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Goodmeds Levocetirizine Dihydrochloride 5mg 365 count
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1
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 · 7 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82725-4051-1 82725405101 365 TABLET in 1 BOTTLE (82725-4051-1) 365 tablet 2026-06-30 No No Current