Home NDC 63629-2533 levocetirizine dihydrochloride
Product NDC 63629-2533
11-digit product format 636292533
Labeler code 63629
Product ID 63629-2533_acc7fd37-12cc-4319-ac53-eb35e3e18d04
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levocetirizine dihydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA091263
Marketing category ANDA
Marketing start 2011-11-07
Substance LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength .5 mg/mL
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 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 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091263-001 AA
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 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091263-001 LEVOCETIRIZINE DIHYDROCHLORIDE 2.5MG/5ML SOLUTION / ORAL AA RS 2011-11-07 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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/mL
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 855168 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 63629-2533-1 levocetirizine dihydrochloride 148 mL in 1 BOTTLE SOLUTION 148 108 63629-2533-1 levocetirizine dihydrochloride 1 in 1 CARTON SOLUTION 1 108
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-2533 LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [BRYANT RANCH PREPACK] 108 Current NDC, Legacy NDC, 2 package rows 20240921_628c26f0-f6bb-4658-ba50-8ca04cd859cb.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 63629-2533-1 63629253301 1 BOTTLE in 1 CARTON (63629-2533-1) / 148 mL in 1 BOTTLE 1 bottle 2011-11-07 0000-00-00 No No Current