Home NDC 42571-312 Levocetirizine Dihydrochloride
Product NDC 42571-312
11-digit product format 425710312
Labeler code 42571
Product ID 42571-312_2e504864-a08d-48e1-e063-6394a90a92ed
Type HUMAN OTC DRUG
Nonproprietary name Levocetirizine Dihydrochloride
Dosage form TABLET
Route ORAL
Labeler Micro Labs Limited
Application ANDA211551
Marketing category ANDA
Marketing start 2019-02-01
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211551-001 LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL 2018-11-20 cb3db0bc1861…
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42571-312-11 Levocetirizine Dihydrochloride 100 in 1 CARTON TABLET 100 6 42571-312-18 Levocetirizine Dihydrochloride 1 in 1 CARTON TABLET 1 6 42571-312-18 Levocetirizine Dihydrochloride 10 in 1 BOTTLE TABLET 10 6 42571-312-32 Levocetirizine Dihydrochloride 10 in 1 BLISTER PACK TABLET 10 6 42571-312-53 Levocetirizine Dihydrochloride 2500 in 1 POUCH TABLET 2500 6 42571-312-90 Levocetirizine Dihydrochloride 90 in 1 BOTTLE TABLET 90 6 42571-312-90 Levocetirizine Dihydrochloride 1 in 1 CARTON TABLET 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42571-312 LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET [MICRO LABS LIMITED] 6 Current NDC, Legacy NDC, 7 package rows 20250221_78ff8e86-ee5b-4626-aa81-49e974febf1d.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 · 2 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 42571-312-11 42571031211 100 BLISTER PACK in 1 CARTON (42571-312-11) / 10 TABLET in 1 BLISTER PACK (42571-312-32) 100 blister pack 2019-02-01 0000-00-00 No No Current 42571-312-18 42571031218 1 BOTTLE in 1 CARTON (42571-312-18) / 10 TABLET in 1 BOTTLE 1 bottle 2019-02-01 0000-00-00 No No Current 42571-312-32 42571031232 10 in 1 BLISTER PACK Historical 42571-312-53 42571031253 2500 TABLET in 1 POUCH (42571-312-53) 2500 tablet 2019-02-01 0000-00-00 No No Current 42571-312-90 42571031290 1 BOTTLE in 1 CARTON (42571-312-90) / 90 TABLET in 1 BOTTLE 1 bottle 2019-02-01 0000-00-00 No No Current