levocetirizine dihydrochloride

Product NDC
11673-847
11-digit product format
116730847
Labeler code
11673
Product ID
11673-847_35fedca9-3c7b-5252-e99f-a62f55564e69
Type
HUMAN OTC DRUG
Nonproprietary name
levocetirizine dihydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Target Corporation
Application
ANDA210375
Marketing category
ANDA
Marketing start
2018-12-31
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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-847LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]7Current NDC, Legacy NDC20241024_7e933c85-96b0-b103-e26a-1aa8a1ded58e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN7e933c85-96b0-b103-e26a-1aa8a1ded58e9
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD7e933c85-96b0-b103-e26a-1aa8a1ded58e9
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY7e933c85-96b0-b103-e26a-1aa8a1ded58e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-847-16116730847162 BOTTLE in 1 CARTON (11673-847-16) / 80 TABLET, COATED in 1 BOTTLE2 bottle2020-12-010000-00-00NoNoCurrent
11673-847-35116730847351 BOTTLE in 1 CARTON (11673-847-35) / 35 TABLET, COATED in 1 BOTTLE1 bottle2018-12-310000-00-00NoNoCurrent
11673-847-79116730847792 BLISTER PACK in 1 BLISTER PACK (11673-847-79) > 5 TABLET, COATED in 1 BLISTER PACK2 blister pack2018-12-310000-00-00NoNoCurrent
11673-847-80116730847801 BOTTLE in 1 CARTON (11673-847-80) / 80 TABLET, COATED in 1 BOTTLE1 bottle2018-12-310000-00-00NoNoCurrent