levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocetirizine dihydrochloride
Generic Name levocetirizine dihydrochloride
Labeler northwind health company, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 5 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 51655-148
Product ID 51655-148_499e8a3e-9b27-9655-e063-6294a90a3be8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091264
Listing Expiration 2027-12-31
Marketing Start 2022-10-04

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 51655148
Hyphenated Format 51655-148

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 ANDA091264 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (51655-148-52)
source: ndc

Packages (1)

51655-148-52 30 TABLET in 1 BOTTLE, PLASTIC (51655-148-52)

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": "499e8a3e-9b27-9655-e063-6294a90a3be8", "openfda": {"unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["f2b458d6-ac10-0fed-e053-2a95a90a0f9c"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (51655-148-52)", "package_ndc": "51655-148-52", "marketing_start_date": "20221004"}], "brand_name": "Levocetirizine Dihydrochloride", "product_id": "51655-148_499e8a3e-9b27-9655-e063-6294a90a3be8", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "51655-148", "generic_name": "Levocetirizine Dihydrochloride", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levocetirizine Dihydrochloride", "active_ingredients": [{"name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA091264", "marketing_category": "ANDA", "marketing_start_date": "20221004", "listing_expiration_date": "20271231"}