levocetirizine dihydrochloride

Product NDC
11822-5252
11-digit product format
118225252
Labeler code
11822
Product ID
11822-5252_3f0e3c1a-a17e-7357-0325-6fb7bea65d6a
Type
HUMAN OTC DRUG
Nonproprietary name
levocetirizine dihydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA210375
Marketing category
ANDA
Marketing start
2020-02-15
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
11822-5252-1levocetirizine dihydrochloride120 in 1 BOTTLETABLET, COATED1203
11822-5252-1levocetirizine dihydrochloride1 in 1 CARTONTABLET, COATED13
11822-5252-7levocetirizine dihydrochloride35 in 1 BOTTLETABLET, COATED353
11822-5252-7levocetirizine dihydrochloride1 in 1 CARTONTABLET, COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-5252LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [RITE AID CORPORATION]2Current NDC, Legacy NDC, 4 package rows20231014_fafc8149-d59a-1253-ae79-f33a088e3769.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSNfafc8149-d59a-1253-ae79-f33a088e37693
855172levocetirizine dihydrochloride 5 MG Oral TabletSCDfafc8149-d59a-1253-ae79-f33a088e37693
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSYfafc8149-d59a-1253-ae79-f33a088e37693

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-5252-1118225252011 BOTTLE in 1 CARTON (11822-5252-1) / 120 TABLET, COATED in 1 BOTTLE1 bottle2020-02-150000-00-00NoNoCurrent
11822-5252-7118225252071 BOTTLE in 1 CARTON (11822-5252-7) / 35 TABLET, COATED in 1 BOTTLE1 bottle2020-02-150000-00-00NoNoCurrent