Home NDC 42571-122 Levocetirizine Dihydrochloride
Product NDC 42571-122
11-digit product format 425710122
Labeler code 42571
Product ID 42571-122_3b48813c-9d13-7de6-e063-6294a90ac278
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name levocetirizine Dihydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Micro Labs Limited
Application ANDA202046
Marketing category ANDA
Marketing start 2013-09-30
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 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 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202046-001 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 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202046-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL AB 2013-09-17 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 42571-122-05 Levocetirizine Dihydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 22 42571-122-11 Levocetirizine Dihydrochloride 10 in 1 BLISTER PACK TABLET, FILM COATED 10 22 42571-122-30 Levocetirizine Dihydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 22 42571-122-32 Levocetirizine Dihydrochloride 10 in 1 CARTON TABLET, FILM COATED 10 22 42571-122-90 Levocetirizine Dihydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 22
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVOCETIRIZINE DIHYDROCHLORIDE ACTIVE INGREDIENT SOD6A38AGA LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [MICRO LABS LIMITED] 5 LEVOCETIRIZINE ACTIVE MOIETY 6U5EA9RT2O LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [MICRO LABS LIMITED] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [MICRO LABS LIMITED] 5 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [MICRO LABS LIMITED] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [MICRO LABS LIMITED] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [MICRO LABS LIMITED] 5 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [MICRO LABS LIMITED] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [MICRO LABS LIMITED] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [MICRO LABS LIMITED] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42571-122 LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [MICRO LABS LIMITED] 20 Current NDC, Legacy NDC, 5 package rows 20250515_717eb542-3a05-485e-be76-3930efb40d33.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 · 5 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 42571-122-05 42571012205 500 TABLET, FILM COATED in 1 BOTTLE (42571-122-05) 2013-09-30 0000-00-00 No No Current 42571-122-11 42571012211 10 in 1 BLISTER PACK Historical 42571-122-30 42571012230 30 TABLET, FILM COATED in 1 BOTTLE (42571-122-30) 2013-09-30 0000-00-00 No No Current 42571-122-32 42571012232 10 BLISTER PACK in 1 CARTON (42571-122-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-122-11) 10 blister pack 2013-09-30 0000-00-00 No No Current 42571-122-90 42571012290 90 TABLET, FILM COATED in 1 BOTTLE (42571-122-90) 2013-09-30 0000-00-00 No No Current