levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

Labeler: sam's west inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocetirizine dihydrochloride
Generic Name levocetirizine dihydrochloride
Labeler sam's west inc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 5 mg/1

Manufacturer
SAM'S WEST INC

Identifiers & Regulatory

Product NDC 68196-406
Product ID 68196-406_35231680-b77b-f06e-11a5-a2107565afd1
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210375
Listing Expiration 2027-12-31
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 68196406
Hyphenated Format 68196-406

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 CARTON (68196-406-20) / 200 TABLET, COATED in 1 BOTTLE (68196-406-02)
source: ndc

Packages (1)

68196-406-20 2 BOTTLE in 1 CARTON (68196-406-20) / 200 TABLET, COATED in 1 BOTTLE (68196-406-02)

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": "35231680-b77b-f06e-11a5-a2107565afd1", "openfda": {"unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["bb8d38b2-117a-fc6b-4ba0-0bc0188cbcd1"], "manufacturer_name": ["SAM'S WEST INC"]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE in 1 CARTON (68196-406-20)  / 200 TABLET, COATED in 1 BOTTLE (68196-406-02)", "package_ndc": "68196-406-20", "marketing_start_date": "20231027"}], "brand_name": "levocetirizine dihydrochloride", "product_id": "68196-406_35231680-b77b-f06e-11a5-a2107565afd1", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68196-406", "generic_name": "levocetirizine dihydrochloride", "labeler_name": "SAM'S WEST INC", "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": "20271231"}