Curist Allergy Relief

Product NDC
72559-007
11-digit product format
725590007
Labeler code
72559
Product ID
72559-007_e4a9cbd2-d165-0f95-e053-2a95a90a07f1
Type
HUMAN OTC DRUG
Nonproprietary name
Levocetirizine dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Little Pharma, Inc.
Application
ANDA211551
Marketing category
ANDA
Marketing start
2019-10-15
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72559-007DDiscontinued by firm2026-08-10
excluded packagepackage72559-00772559-007-05DDiscontinued by firm2026-08-10

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 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage72559-007-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage72559-007-05DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage72559-007-05DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage72559-007-05DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage72559-007-05DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage72559-007-05DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage72559-007-05DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72559-007-05DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72559-007-05DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage72559-007-05DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage72559-007-05IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage72559-007-05IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage72559-007-05IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage72559-007-05IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage72559-007-05IInactivated by FDA1332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211551-001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-203f01610625f2…
2019-09-15 20:21 UTC2019-09A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72559-007-052024-11-05C16284748780-11030e365-130d-111a-e063-dadaa90a10e2Curist Allergy Relief (Levocetirizine) Tablets
72559-007-052024-01-30C16284748780-11030e365-130d-111a-e063-dadaa90a10e2Curist Allergy Relief (Levocetirizine) Tablets

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEMicro Labs Limited78ff8e86-ee5b-4626-aa81-49e974febf1d2025-02-16WarningsExact identifier
application applno (ANDA): 211551
application number: ANDA211551
Allergy Relief 24HRLEVOCETIRIZINE DIHYDROCHLORIDEVELOCITY PHARMA LLC8ba208dc-34fe-453a-8658-ed4f232e1a942024-10-29WarningsExact identifier
application applno (ANDA): 211551
application number: ANDA211551

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72559-007-05725590007051 BOTTLE in 1 CARTON (72559-007-05) > 90 TABLET in 1 BOTTLE1 bottle2019-10-150000-00-00NoNoCurrent