good sense levocetirizine

Product NDC
0113-0241
11-digit product format
001130241
Labeler code
0113
Product ID
0113-0241_618aa954-63d9-4dbf-aeec-ed7a05083fd4
Type
HUMAN OTC DRUG
Nonproprietary name
levocetirizine dihydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA211983
Marketing category
ANDA
Marketing start
2020-09-11
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
good sense levocetirizine
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
0113-0241-01good sense levocetirizine1 in 1 CARTONTABLET, FILM COATED12
0113-0241-01good sense levocetirizine35 in 1 BOTTLETABLET, FILM COATED352

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0241-01EA - Each0113-02413e4e9a38-e1d9-4243-bb4e-843dbdc92e0812022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0241GOOD SENSE LEVOCETIRIZINE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [L. PERRIGO COMPANY]2Current NDC, Legacy NDC, 2 package rows20250522_0b482364-a00a-4b95-975a-f403a3ae4d2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN0b482364-a00a-4b95-975a-f403a3ae4d2e2
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD0b482364-a00a-4b95-975a-f403a3ae4d2e2
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY0b482364-a00a-4b95-975a-f403a3ae4d2e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0241-01001130241011 BOTTLE in 1 CARTON (0113-0241-01) / 35 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-09-110000-00-00NoNoCurrent