FDA.reportPublic FDA data

Levocetirizine Dihydrochloride

Product NDC
42571-312
11-digit product format
425710312
Labeler code
42571
Product ID
42571-312_2e504864-a08d-48e1-e063-6394a90a92ed
Type
HUMAN OTC DRUG
Nonproprietary name
Levocetirizine Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA211551
Marketing category
ANDA
Marketing start
2019-02-01
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

Additional Listing Data#

Finished product
Yes
Brand name base
Levocetirizine Dihydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOCETIRIZINE DIHYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOD6A38AGA
Rxcui855172

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
42571-312-112025-02-17C16284748780-12cef2736-ab1e-d83d-e063-dadaa90ab31fDrug Facts
42571-312-182025-02-17C16284748780-12cef2736-ab1e-d83d-e063-dadaa90ab31fDrug Facts
42571-312-532025-02-17C16284748780-12cef2736-ab1e-d83d-e063-dadaa90ab31fDrug Facts
42571-312-902025-02-17C16284748780-12cef2736-ab1e-d83d-e063-dadaa90ab31fDrug Facts
42571-312-112025-01-30C16284748780-12cef2736-ab1e-d83d-e063-dadaa90ab31fDrug Facts
42571-312-182025-01-30C16284748780-12cef2736-ab1e-d83d-e063-dadaa90ab31fDrug Facts
42571-312-532025-01-30C16284748780-12cef2736-ab1e-d83d-e063-dadaa90ab31fDrug Facts
42571-312-902025-01-30C16284748780-12cef2736-ab1e-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-312-11Levocetirizine Dihydrochloride100 in 1 CARTONTABLET1006
42571-312-18Levocetirizine Dihydrochloride1 in 1 CARTONTABLET16
42571-312-18Levocetirizine Dihydrochloride10 in 1 BOTTLETABLET106
42571-312-32Levocetirizine Dihydrochloride10 in 1 BLISTER PACKTABLET106
42571-312-53Levocetirizine Dihydrochloride2500 in 1 POUCHTABLET25006
42571-312-90Levocetirizine Dihydrochloride90 in 1 BOTTLETABLET906
42571-312-90Levocetirizine Dihydrochloride1 in 1 CARTONTABLET16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-312LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET [MICRO LABS LIMITED]6Current NDC, Legacy NDC, 7 package rows20250221_78ff8e86-ee5b-4626-aa81-49e974febf1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN78ff8e86-ee5b-4626-aa81-49e974febf1d6
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD78ff8e86-ee5b-4626-aa81-49e974febf1d6
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY78ff8e86-ee5b-4626-aa81-49e974febf1d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-312-1142571031211100 BLISTER PACK in 1 CARTON (42571-312-11) / 10 TABLET in 1 BLISTER PACK (42571-312-32) 100 blister pack2019-02-010000-00-00NoNoCurrent
42571-312-18425710312181 BOTTLE in 1 CARTON (42571-312-18) / 10 TABLET in 1 BOTTLE1 bottle2019-02-010000-00-00NoNoCurrent
42571-312-324257103123210 in 1 BLISTER PACKHistorical
42571-312-53425710312532500 TABLET in 1 POUCH (42571-312-53) 2500 tablet2019-02-010000-00-00NoNoCurrent
42571-312-90425710312901 BOTTLE in 1 CARTON (42571-312-90) / 90 TABLET in 1 BOTTLE1 bottle2019-02-010000-00-00NoNoCurrent