Home NDC 71335-1305 Levocetirizine Dihydrochloride
Product NDC 71335-1305
11-digit product format 713351305
Labeler code 71335
Product ID 71335-1305_3214c803-6a3c-40c3-ab29-1088452d7788
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name levocetirizine Dihydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
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 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 2 · 65 matching rows.
View current auxiliary records. · View the auxiliary file history.
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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 71335-1305-1 2025-06-27 These highlights do not include all the information needed to use LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS. LEVOCETIRIZINE dihydrochloride tablets, for oral use Initial U.S. Approval: 1995 71335-1305-2 2025-06-27 These highlights do not include all the information needed to use LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS. LEVOCETIRIZINE dihydrochloride tablets, for oral use Initial U.S. Approval: 1995 71335-1305-3 2025-06-27 These highlights do not include all the information needed to use LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS. LEVOCETIRIZINE dihydrochloride tablets, for oral use Initial U.S. Approval: 1995 71335-1305-4 2025-06-27 These highlights do not include all the information needed to use LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS. LEVOCETIRIZINE dihydrochloride tablets, for oral use Initial U.S. Approval: 1995 71335-1305-1 2024-01-30 These highlights do not include all the information needed to use LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS. LEVOCETIRIZINE dihydrochloride tablets, for oral use Initial U.S. Approval: 1995 71335-1305-2 2024-01-30 These highlights do not include all the information needed to use LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS. LEVOCETIRIZINE dihydrochloride tablets, for oral use Initial U.S. Approval: 1995 71335-1305-3 2024-01-30 These highlights do not include all the information needed to use LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS. LEVOCETIRIZINE dihydrochloride tablets, for oral use Initial U.S. Approval: 1995 71335-1305-4 2024-01-30 These highlights do not include all the information needed to use LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS. LEVOCETIRIZINE dihydrochloride tablets, for oral use Initial U.S. Approval: 1995
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-1305-1 Levocetirizine Dihydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 3 71335-1305-2 Levocetirizine Dihydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 3 71335-1305-3 Levocetirizine Dihydrochloride 28 in 1 BOTTLE TABLET, FILM COATED 28 3 71335-1305-4 Levocetirizine Dihydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1305 LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK] 2 Current NDC, Legacy NDC, 4 package rows 20220204_e885f084-9ce2-4e0c-aadb-c9d651224e5b.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 Marketing start Marketing end Sample Exclude flag Status 71335-1305-1 71335130501 30 TABLET, FILM COATED in 1 BOTTLE (71335-1305-1) 2019-09-05 0000-00-00 No No Current 71335-1305-2 71335130502 90 TABLET, FILM COATED in 1 BOTTLE (71335-1305-2) 2021-03-09 0000-00-00 No No Current 71335-1305-3 71335130503 28 TABLET, FILM COATED in 1 BOTTLE (71335-1305-3) 2025-06-27 0000-00-00 No No Current 71335-1305-4 71335130504 60 TABLET, FILM COATED in 1 BOTTLE (71335-1305-4) 2025-06-27 0000-00-00 No No Current