Levocetirizine Dihydrochloride

Product NDC
71205-210
11-digit product format
712050210
Labeler code
71205
Product ID
71205-210_1913d2a6-6558-4d2b-bc1e-54cdef6623eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levocetirizine Dihydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202046
Marketing category
ANDA
Marketing start
2013-09-30
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
71205-210-30Levocetirizine Dihydrochloride30 in 1 BOTTLETABLET, FILM COATED303
71205-210-60Levocetirizine Dihydrochloride60 in 1 BOTTLETABLET, FILM COATED603
71205-210-90Levocetirizine Dihydrochloride90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-210-30EA - Each71205-21085044dc4-4af9-4a8a-a4b6-761e3ffb8e5412019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-210LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20200111_f10cfe9a-1884-4a65-b827-8fd781fb75c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSNf10cfe9a-1884-4a65-b827-8fd781fb75c43
855172levocetirizine dihydrochloride 5 MG Oral TabletSCDf10cfe9a-1884-4a65-b827-8fd781fb75c43
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSYf10cfe9a-1884-4a65-b827-8fd781fb75c43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-210-307120502103030 TABLET, FILM COATED in 1 BOTTLE (71205-210-30) 2019-01-010000-00-00NoNoCurrent
71205-210-607120502106060 TABLET, FILM COATED in 1 BOTTLE (71205-210-60) 2019-01-010000-00-00NoNoCurrent
71205-210-907120502109090 TABLET, FILM COATED in 1 BOTTLE (71205-210-90) 2019-01-010000-00-00NoNoCurrent