Home NDC 41167-5803 Xyzal
Product NDC 41167-5803
11-digit product format 411675803
Labeler code 41167
Product ID 41167-5803_87a83f00-5abf-437d-af13-394c22964050
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name levocetirizine dihydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Chattem, Inc.
Application NDA022064
Marketing category NDA
Marketing start 2017-07-24
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 N022064-001 XYZAL LEVOCETIRIZINE DIHYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25
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 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022064-001 XYZAL 5MG TABLET / ORAL RLD 2007-05-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022064-001 XYZAL 5MG TABLET / ORAL RLD 2007-05-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022064-001 XYZAL 5MG TABLET / ORAL RLD 2007-05-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022064-001 XYZAL 5MG TABLET / ORAL AB RLD, RS 2007-05-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022064-001 XYZAL 5MG TABLET / ORAL RLD 2007-05-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022064-001 XYZAL 5MG TABLET / ORAL RLD 2007-05-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022064-001 XYZAL 5MG TABLET / ORAL AB RLD, RS 2007-05-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022064-001 XYZAL 5MG TABLET / ORAL AB RLD, RS 2007-05-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022064-001 XYZAL 5MG TABLET / ORAL AB RLD, RS 2007-05-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022064-001 XYZAL 5MG TABLET / ORAL AB RLD, RS 2007-05-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022064-001 XYZAL 5MG TABLET / ORAL AB RLD, RS 2007-05-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022064-001 XYZAL 5MG TABLET / ORAL AB RLD, RS 2007-05-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022064-001 XYZAL 5MG TABLET / ORAL AB RLD, RS 2007-05-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022064-001 XYZAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-05-25 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Xyzal
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 855168 Internal RxNorm lookup 855170 Internal RxNorm lookup 855172 Internal RxNorm lookup 855174 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 41167-5803-9 Xyzal 90 in 1 BOTTLE TABLET, FILM COATED 90 2
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Xyzal LEVOCETIRIZINE DIHYDROCHLORIDE Chattem, Inc. 1673f7ff-0c7c-4403-86cf-c05eb1475222 2025-07-22 Warnings, Adverse reactions Exact identifier application applno (NDA): 022064 application number: NDA022064 ndc (product): 41167-5803
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 41167-5803-9 41167580309 90 TABLET, FILM COATED in 1 BOTTLE (41167-5803-9) 2017-07-24 No No Current