levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

Labeler: camber consumer care inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocetirizine dihydrochloride
Generic Name levocetirizine dihydrochloride
Labeler camber consumer care inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 5 mg/1

Manufacturer
Camber Consumer Care Inc

Identifiers & Regulatory

Product NDC 69230-321
Product ID 69230-321_7ca0cee0-b628-4266-b361-ad5c52b6f11e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA213513
Listing Expiration 2026-12-31
Marketing Start 2020-10-28

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69230321
Hyphenated Format 69230-321

Supplemental Identifiers

RxCUI
855172
UPC
0369230321317
UNII
SOD6A38AGA

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name levocetirizine dihydrochloride (source: ndc)
Generic Name levocetirizine dihydrochloride (source: ndc)
Application Number ANDA213513 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (69230-321-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 1000 TABLET, FILM COATED in 1 BOTTLE (69230-321-10)
  • 1 BOTTLE in 1 CARTON (69230-321-31) / 35 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (69230-321-32) / 55 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (69230-321-33) / 80 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (69230-321-34) / 180 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (6)

69230-321-01 10 BLISTER PACK in 1 CARTON (69230-321-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK 69230-321-10 1000 TABLET, FILM COATED in 1 BOTTLE (69230-321-10) 69230-321-31 1 BOTTLE in 1 CARTON (69230-321-31) / 35 TABLET, FILM COATED in 1 BOTTLE 69230-321-32 1 BOTTLE in 1 CARTON (69230-321-32) / 55 TABLET, FILM COATED in 1 BOTTLE 69230-321-33 1 BOTTLE in 1 CARTON (69230-321-33) / 80 TABLET, FILM COATED in 1 BOTTLE 69230-321-34 1 BOTTLE in 1 CARTON (69230-321-34) / 180 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

levocetirizine dihydrochloride (5 mg/1)

Linked Drug Pages (1)

Levocetirizine Dihydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7ca0cee0-b628-4266-b361-ad5c52b6f11e", "openfda": {"upc": ["0369230321317"], "unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["be72dafb-62ae-40b2-874f-1d8920fad19d"], "manufacturer_name": ["Camber Consumer Care Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (69230-321-01)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "69230-321-01", "marketing_start_date": "20201028"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (69230-321-10)", "package_ndc": "69230-321-10", "marketing_start_date": "20201028"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69230-321-31)  / 35 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "69230-321-31", "marketing_start_date": "20201028"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69230-321-32)  / 55 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "69230-321-32", "marketing_start_date": "20201028"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69230-321-33)  / 80 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "69230-321-33", "marketing_start_date": "20201028"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69230-321-34)  / 180 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "69230-321-34", "marketing_start_date": "20201028"}], "brand_name": "Levocetirizine Dihydrochloride", "product_id": "69230-321_7ca0cee0-b628-4266-b361-ad5c52b6f11e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69230-321", "generic_name": "Levocetirizine Dihydrochloride", "labeler_name": "Camber Consumer Care Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Levocetirizine Dihydrochloride", "active_ingredients": [{"name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA213513", "marketing_category": "ANDA", "marketing_start_date": "20201028", "listing_expiration_date": "20261231"}