Levocetirizine Dihydrochloride

Product NDC
69117-1000
11-digit product format
691171000
Labeler code
69117
Product ID
69117-1000_9c134fe5-26a3-6bb3-e053-2995a90a2ceb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levocetirizine Dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
YILING PHARMACEUTICAL, INC.
Application
ANDA203646
Marketing category
ANDA
Marketing start
2017-03-29
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69117-1000-1Levocetirizine Dihydrochloride90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69117-1000-1EA - Each69117-10000ccdb6ac-10b7-4fef-b8b6-89c9e55eb96f12017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69117-1000LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [YILING PHARMACEUTICAL, INC.]4Legacy NDC, 1 package rows20200114_4aa6f67e-5331-661b-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN4aa6f67e-5331-661b-e054-00144ff88e884
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD4aa6f67e-5331-661b-e054-00144ff88e884
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY4aa6f67e-5331-661b-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69117-1000-16911710000190 TABLET in 1 BOTTLE (69117-1000-1) 90 tablet2017-03-290000-00-00NoNoCurrent