FDA.reportPublic FDA data

Levocetirizine Dihydrochloride

Product NDC
50090-5341
Requested package NDC
50090-5341-1
11-digit product format
500905341
Labeler code
50090
Product ID
50090-5341_ec104719-030c-4cd3-bdf8-09e2ce339eb8
Type
HUMAN OTC DRUG
Nonproprietary name
Levocetirizine Dihydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA213513
Marketing category
ANDA
Marketing start
2020-10-28
Marketing end
0000-00-00
Substance
LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-534150090-5341-1IInactivated by FDA2026-07-31

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
A213513-001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Goodmeds Levocetirizine Dihydrochloride 5mg 365 countLEVOCETIRIZINE DIHYDROCHLORIDE 5MGCabinet Health P.B.C.54f34304-952e-2f07-e063-6394a90a80ee2026-06-23WarningsExact identifier
application applno (ANDA): 213513
application number: ANDA213513
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEFarmacias De Similares TX LLC4ed17484-5609-d993-e063-6294a90a82a22026-04-06WarningsExact identifier
application applno (ANDA): 213513
application number: ANDA213513
Curist Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDE 5 MGLittle Pharma, Inc.f2a2a5bc-2efa-c550-e053-2a95a90a55ff2026-03-05WarningsExact identifier
application applno (ANDA): 213513
application number: ANDA213513
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDESportpharm LLC8c00c74f-4377-4f2c-943e-e55afa5a824f2026-02-14Exact identifier
application applno (ANDA): 213513
application number: ANDA213513
ALLERGY RELIEFLEVOCETIRIZINE DIHYDROCHLORIDEYYBA CORP8ee69332-742d-4071-95df-84bc42e170e72025-12-03WarningsExact identifier
application applno (ANDA): 213513
application number: ANDA213513
Curist Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDE 5 MGLittle Pharma, Inc.feabf140-e283-dcd5-e053-6394a90a29172025-04-16WarningsExact identifier
application applno (ANDA): 213513
application number: ANDA213513
Allery Relief 24HRALLERY RELIEF 24HRAllegiant Healthc523c210-b1c4-4049-9c72-2b31c9c931372024-04-02WarningsExact identifier
application applno (ANDA): 213513
application number: ANDA213513
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDECamber Consumer Care Incbe72dafb-62ae-40b2-874f-1d8920fad19d2020-11-30Exact identifier
application applno (ANDA): 213513
application number: ANDA213513

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760Product name720190702

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5341-02023-01-30C16284748780-1f386c64a-328b-0266-e053-dadaa90a7c1aLevocetirizine Dihydrochloride Tablets USP, 5 mg (OTC)
50090-5341-12023-01-30C16284748780-1f386c64a-328b-0266-e053-dadaa90a7c1aLevocetirizine Dihydrochloride Tablets USP, 5 mg (OTC)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5341-0Levocetirizine Dihydrochloride30 in 1 BOTTLETABLET, FILM COATED303
50090-5341-1Levocetirizine Dihydrochloride90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5341LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20210417_3fad12b0-1bff-4899-99bb-0608b42d3be3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN3fad12b0-1bff-4899-99bb-0608b42d3be33
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD3fad12b0-1bff-4899-99bb-0608b42d3be33
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY3fad12b0-1bff-4899-99bb-0608b42d3be33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5341-15009053410190 TABLET, FILM COATED in 1 BOTTLE (50090-5341-1) 2020-11-040000-00-00NoNoCurrent