levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

Labeler: bjwc (berkley & jensen / bj's)
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocetirizine dihydrochloride
Generic Name levocetirizine dihydrochloride
Labeler bjwc (berkley & jensen / bj's)
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 5 mg/1

Manufacturer
BJWC (Berkley & Jensen / BJ'S)

Identifiers & Regulatory

Product NDC 68391-955
Product ID 68391-955_6098f8c4-4502-287f-cd05-06e17d773116
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210375
Listing Expiration 2026-12-31
Marketing Start 2020-06-24

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 68391955
Hyphenated Format 68391-955

Supplemental Identifiers

RxCUI
855172
UNII
SOD6A38AGA

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 ANDA210375 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 2 BOTTLE in 1 PACKAGE (68391-955-11) / 55 TABLET, COATED in 1 BOTTLE (68391-955-55)
source: ndc

Packages (1)

68391-955-11 2 BOTTLE in 1 PACKAGE (68391-955-11) / 55 TABLET, COATED in 1 BOTTLE (68391-955-55)

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": "6098f8c4-4502-287f-cd05-06e17d773116", "openfda": {"unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["0216f644-767c-ae88-f48f-cd29ac1547ed"], "manufacturer_name": ["BJWC (Berkley & Jensen / BJ'S)"]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE in 1 PACKAGE (68391-955-11)  / 55 TABLET, COATED in 1 BOTTLE (68391-955-55)", "package_ndc": "68391-955-11", "marketing_start_date": "20240815"}], "brand_name": "levocetirizine dihydrochloride", "product_id": "68391-955_6098f8c4-4502-287f-cd05-06e17d773116", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68391-955", "generic_name": "levocetirizine dihydrochloride", "labeler_name": "BJWC (Berkley & Jensen / BJ'S)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "levocetirizine dihydrochloride", "active_ingredients": [{"name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA210375", "marketing_category": "ANDA", "marketing_start_date": "20200624", "listing_expiration_date": "20261231"}