Home NDC 68462-346 LEVOCETIRIZINE DIHYDROCHLORIDE
Product NDC 68462-346
11-digit product format 684620346
Labeler code 68462
Product ID 68462-346_3dc84568-462c-4fca-b235-3a84f8a4bd7e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name levocetirizine dihydrochloride
Dosage form TABLET
Route ORAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA090385
Marketing category ANDA
Marketing start 2011-02-25
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 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 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 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 A090385-001 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 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 2011-02-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090385-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB RS 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 2027-12-31 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 68462-346-90 LEVOCETIRIZINE DIHYDROCHLORIDE 90 in 1 BOTTLE TABLET 90 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVOCETIRIZINE DIHYDROCHLORIDE ACTIVE INGREDIENT SOD6A38AGA LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 7 LEVOCETIRIZINE ACTIVE MOIETY 6U5EA9RT2O LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 7 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 7 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-346 LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 17 Current NDC, Legacy NDC, 1 package rows 20240104_60ae7e0e-281c-40a3-a0d3-259b843ddaaa.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 · 3 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 68462-346-90 68462034690 90 TABLET in 1 BOTTLE (68462-346-90) 90 tablet 2011-02-25 0000-00-00 No No Current