Home NDC 55111-282 levocetirizine dihydrochloride
Product NDC 55111-282
11-digit product format 551110282
Labeler code 55111
Product ID 55111-282_acb3404e-c2a4-f21f-5f5b-f0ceab355395
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name levocetirizine dihydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Dr.Reddy's laboratories Ltd.
Application ANDA090392
Marketing category ANDA
Marketing start 2011-02-24
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 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090392-001 AB
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 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090392-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 55111-282-01 levocetirizine dihydrochloride 100 in 1 BOTTLE TABLET, COATED 100 8 55111-282-05 levocetirizine dihydrochloride 500 in 1 BOTTLE TABLET, COATED 500 8 55111-282-18 levocetirizine dihydrochloride 180 in 1 BOTTLE TABLET, COATED 180 8 55111-282-30 levocetirizine dihydrochloride 30 in 1 BOTTLE TABLET, COATED 30 8 55111-282-60 levocetirizine dihydrochloride 60 in 1 BOTTLE TABLET, COATED 60 8 55111-282-78 levocetirizine dihydrochloride 10 in 1 CARTON TABLET, COATED 10 8 55111-282-79 levocetirizine dihydrochloride 10 in 1 BLISTER PACK TABLET, COATED 10 8 55111-282-90 levocetirizine dihydrochloride 90 in 1 BOTTLE TABLET, COATED 90 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded levocetirizine dihydrochloride ACTIVE INGREDIENT SOD6A38AGA LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [DR.REDDY'S LABORATORIES LTD.] 6 levocetirizine ACTIVE MOIETY 6U5EA9RT2O LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [DR.REDDY'S LABORATORIES LTD.] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [DR.REDDY'S LABORATORIES LTD.] 6 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [DR.REDDY'S LABORATORIES LTD.] 6 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [DR.REDDY'S LABORATORIES LTD.] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [DR.REDDY'S LABORATORIES LTD.] 6 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [DR.REDDY'S LABORATORIES LTD.] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [DR.REDDY'S LABORATORIES LTD.] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [DR.REDDY'S LABORATORIES LTD.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-282 LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [DR.REDDY'S LABORATORIES LTD.] 8 Current NDC, Legacy NDC, 8 package rows 20181211_c40c1bb4-25ce-90cb-b8dd-6a4c54cddd4a.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 · 1 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 55111-282-01 55111028201 100 TABLET, COATED in 1 BOTTLE (55111-282-01) 2011-02-24 0000-00-00 No No Current 55111-282-05 55111028205 500 TABLET, COATED in 1 BOTTLE (55111-282-05) 2011-02-24 0000-00-00 No No Current 55111-282-18 55111028218 180 TABLET, COATED in 1 BOTTLE (55111-282-18) 2011-02-24 0000-00-00 No No Current 55111-282-30 55111028230 30 TABLET, COATED in 1 BOTTLE (55111-282-30) 2011-02-24 0000-00-00 No No Current 55111-282-60 55111028260 60 TABLET, COATED in 1 BOTTLE (55111-282-60) 2011-02-24 0000-00-00 No No Current 55111-282-78 55111028278 10 BLISTER PACK in 1 CARTON (55111-282-78) / 10 TABLET, COATED in 1 BLISTER PACK (55111-282-79) 10 blister pack 2011-02-24 0000-00-00 No No Current 55111-282-79 55111028279 10 in 1 BLISTER PACK Historical 55111-282-90 55111028290 90 TABLET, COATED in 1 BOTTLE (55111-282-90) 2011-02-24 0000-00-00 No No Current