Home NDC 11822-5252 levocetirizine dihydrochloride
Product NDC 11822-5252
11-digit product format 118225252
Labeler code 11822
Product ID 11822-5252_3f0e3c1a-a17e-7357-0325-6fb7bea65d6a
Type HUMAN OTC DRUG
Nonproprietary name levocetirizine dihydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Rite Aid Corporation
Application ANDA210375
Marketing category ANDA
Marketing start 2020-02-15
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 2026-12-31
Current FDA listing Yes 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…
Additional Listing Data#
Finished product Yes
Brand name base levocetirizine dihydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOD6A38AGA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 855172 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11822-5252-1 levocetirizine dihydrochloride 120 in 1 BOTTLE TABLET, COATED 120 3 11822-5252-1 levocetirizine dihydrochloride 1 in 1 CARTON TABLET, COATED 1 3 11822-5252-7 levocetirizine dihydrochloride 35 in 1 BOTTLE TABLET, COATED 35 3 11822-5252-7 levocetirizine dihydrochloride 1 in 1 CARTON TABLET, COATED 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11822-5252 LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [RITE AID CORPORATION] 2 Current NDC, Legacy NDC, 4 package rows 20231014_fafc8149-d59a-1253-ae79-f33a088e3769.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.
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 11822-5252-1 11822525201 1 BOTTLE in 1 CARTON (11822-5252-1) / 120 TABLET, COATED in 1 BOTTLE 1 bottle 2020-02-15 0000-00-00 No No Current 11822-5252-7 11822525207 1 BOTTLE in 1 CARTON (11822-5252-7) / 35 TABLET, COATED in 1 BOTTLE 1 bottle 2020-02-15 0000-00-00 No No Current