FDA.reportPublic FDA data

Levocetirizine Dihydrochloride

Product NDC
69230-321
11-digit product format
692300321
Labeler code
69230
Product ID
69230-321_7ca0cee0-b628-4266-b361-ad5c52b6f11e
Type
HUMAN OTC DRUG
Nonproprietary name
Levocetirizine Dihydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Consumer Care Inc
Application
ANDA213513
Marketing category
ANDA
Marketing start
2020-10-28
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
69230-321-01Levocetirizine Dihydrochloride10 in 1 CARTONTABLET, FILM COATED104
69230-321-01Levocetirizine Dihydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED104
69230-321-10Levocetirizine Dihydrochloride1000 in 1 BOTTLETABLET, FILM COATED10004
69230-321-31Levocetirizine Dihydrochloride1 in 1 CARTONTABLET, FILM COATED14
69230-321-31Levocetirizine Dihydrochloride35 in 1 BOTTLETABLET, FILM COATED354
69230-321-32Levocetirizine Dihydrochloride1 in 1 CARTONTABLET, FILM COATED14
69230-321-32Levocetirizine Dihydrochloride55 in 1 BOTTLETABLET, FILM COATED554
69230-321-33Levocetirizine Dihydrochloride80 in 1 BOTTLETABLET, FILM COATED804
69230-321-33Levocetirizine Dihydrochloride1 in 1 CARTONTABLET, FILM COATED14
69230-321-34Levocetirizine Dihydrochloride1 in 1 CARTONTABLET, FILM COATED14
69230-321-34Levocetirizine Dihydrochloride180 in 1 BOTTLETABLET, FILM COATED1804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69230-321-10EA - Each69230-32184a2a231-d14a-401d-9979-adec87d0ed5312021-01-08
69230-321-31EA - Each69230-32100dec7c6-cc7e-43c1-a75f-a5608954646912021-01-08
69230-321-33EA - Each69230-32133452538-def5-4491-9a09-fab29865059f12021-01-08
69230-321-34EA - Each69230-3212c505c0b-13ca-49dd-a26e-ed381568e57512023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69230-321LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [CAMBER CONSUMER CARE INC]4Current NDC, Legacy NDC, 11 package rows20201201_be72dafb-62ae-40b2-874f-1d8920fad19d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSNbe72dafb-62ae-40b2-874f-1d8920fad19d4
855172levocetirizine dihydrochloride 5 MG Oral TabletSCDbe72dafb-62ae-40b2-874f-1d8920fad19d4
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSYbe72dafb-62ae-40b2-874f-1d8920fad19d4
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN3fad12b0-1bff-4899-99bb-0608b42d3be33
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD3fad12b0-1bff-4899-99bb-0608b42d3be33
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY3fad12b0-1bff-4899-99bb-0608b42d3be33
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN8c00c74f-4377-4f2c-943e-e55afa5a824f1
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD8c00c74f-4377-4f2c-943e-e55afa5a824f1
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY8c00c74f-4377-4f2c-943e-e55afa5a824f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69230-321-016923003210110 BLISTER PACK in 1 CARTON (69230-321-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2020-10-280000-00-00NoNoCurrent
69230-321-10692300321101000 TABLET, FILM COATED in 1 BOTTLE (69230-321-10) 2020-10-280000-00-00NoNoCurrent
69230-321-31692300321311 BOTTLE in 1 CARTON (69230-321-31) / 35 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-10-280000-00-00NoNoCurrent
69230-321-32692300321321 BOTTLE in 1 CARTON (69230-321-32) / 55 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-10-280000-00-00NoNoCurrent
69230-321-33692300321331 BOTTLE in 1 CARTON (69230-321-33) / 80 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-10-280000-00-00NoNoCurrent
69230-321-34692300321341 BOTTLE in 1 CARTON (69230-321-34) / 180 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-10-280000-00-00NoNoCurrent
69230-321-366923003213610000 TABLET, FILM COATED in 1 BAG (69230-321-36)16-JAN-25Current