FDA.reportPublic FDA data

LEVOCETIRIZINE DIHYDROCHLORIDE

Product NDC
33342-200
11-digit product format
333420200
Labeler code
33342
Product ID
33342-200_af9c84cc-0f32-4489-a65b-aaa9d93e65e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOCETIRIZINE DIHYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA205564
Marketing category
ANDA
Marketing start
2016-01-11
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-200-07LEVOCETIRIZINE DIHYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED3010
33342-200-10LEVOCETIRIZINE DIHYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-200-10EA - Each33342-200953d333f-4d93-47fc-900b-7d8f232a774912017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-200LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9Current NDC, Legacy NDC, 2 package rows20221019_8a3c06a5-4a9a-4205-8ae7-c58efeb73c58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN8a3c06a5-4a9a-4205-8ae7-c58efeb73c5810
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD8a3c06a5-4a9a-4205-8ae7-c58efeb73c5810
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY8a3c06a5-4a9a-4205-8ae7-c58efeb73c5810
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN1b593c65-2866-45d9-9c94-ac181f4cbc518
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD1b593c65-2866-45d9-9c94-ac181f4cbc518
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY1b593c65-2866-45d9-9c94-ac181f4cbc518
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN7a7dae67-6e24-511a-e053-2a91aa0acb444
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD7a7dae67-6e24-511a-e053-2a91aa0acb444
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY7a7dae67-6e24-511a-e053-2a91aa0acb444
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN87c4d9c1-db12-9b61-e053-2995a90abfec2
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD87c4d9c1-db12-9b61-e053-2995a90abfec2
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY87c4d9c1-db12-9b61-e053-2995a90abfec2
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN5d6941c7-ef0a-48d3-93dc-53bc2c9789de1
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD5d6941c7-ef0a-48d3-93dc-53bc2c9789de1
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY5d6941c7-ef0a-48d3-93dc-53bc2c9789de1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
33342-200-073334202000730 TABLET, FILM COATED in 1 BOTTLE (33342-200-07) 2016-01-110000-00-00NoNoCurrent
33342-200-103334202001090 TABLET, FILM COATED in 1 BOTTLE (33342-200-10) 2016-01-110000-00-00NoNoCurrent