levocetirizine dihydrochloride

Product NDC
30142-717
11-digit product format
301420717
Labeler code
30142
Product ID
30142-717_1a7ae26e-cc7d-442a-8308-48d31a3ade4f
Type
HUMAN OTC DRUG
Nonproprietary name
levocetirizine dihydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
KROGER COMPANY
Application
ANDA210375
Marketing category
ANDA
Marketing start
2018-09-30
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
levocetirizine dihydrochloride
Listing expiration
2027-12-31

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
30142-717-16levocetirizine dihydrochloride2 in 1 CARTONTABLET, COATED26
30142-717-35levocetirizine dihydrochloride35 in 1 BOTTLETABLET, COATED356
30142-717-35levocetirizine dihydrochloride1 in 1 CARTONTABLET, COATED16
30142-717-80levocetirizine dihydrochloride80 in 1 BOTTLETABLET, COATED806

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-717LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [KROGER COMPANY]4Current NDC, Legacy NDC, 4 package rows20231014_e47658af-e0f3-5765-f568-300ba407dc29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSNe47658af-e0f3-5765-f568-300ba407dc296
855172levocetirizine dihydrochloride 5 MG Oral TabletSCDe47658af-e0f3-5765-f568-300ba407dc296
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSYe47658af-e0f3-5765-f568-300ba407dc296

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-717-16301420717162 BOTTLE in 1 CARTON (30142-717-16) / 80 TABLET, COATED in 1 BOTTLE (30142-717-80) 2 bottle2018-09-300000-00-00NoNoCurrent
30142-717-35301420717351 BOTTLE in 1 CARTON (30142-717-35) / 35 TABLET, COATED in 1 BOTTLE1 bottle2018-09-300000-00-00NoNoCurrent
30142-717-803014207178080 in 1 BOTTLEHistorical