levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

Labeler: sciegen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocetirizine dihydrochloride
Generic Name levocetirizine dihydrochloride
Labeler sciegen pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 5 mg/1

Manufacturer
ScieGen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50228-136
Product ID 50228-136_9683b976-3b83-43f0-959c-5f238b84602e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203646
Listing Expiration 2026-12-31
Marketing Start 2014-09-09

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 50228136
Hyphenated Format 50228-136

Supplemental Identifiers

RxCUI
855172
UPC
0350228136907 0350228136303
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 ANDA203646 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (50228-136-10)
  • 30 TABLET in 1 BOTTLE (50228-136-30)
  • 90 TABLET in 1 BOTTLE (50228-136-90)
source: ndc

Packages (3)

50228-136-10 1000 TABLET in 1 BOTTLE (50228-136-10) 50228-136-30 30 TABLET in 1 BOTTLE (50228-136-30) 50228-136-90 90 TABLET in 1 BOTTLE (50228-136-90)

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": "9683b976-3b83-43f0-959c-5f238b84602e", "openfda": {"upc": ["0350228136907", "0350228136303"], "unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["bd7fe481-dfe7-4dfd-aa05-6e2318a9234e"], "manufacturer_name": ["ScieGen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (50228-136-10)", "package_ndc": "50228-136-10", "marketing_start_date": "20140909"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (50228-136-30)", "package_ndc": "50228-136-30", "marketing_start_date": "20140909"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (50228-136-90)", "package_ndc": "50228-136-90", "marketing_start_date": "20140909"}], "brand_name": "levocetirizine dihydrochloride", "product_id": "50228-136_9683b976-3b83-43f0-959c-5f238b84602e", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "50228-136", "generic_name": "levocetirizine dihydrochloride", "labeler_name": "ScieGen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "levocetirizine dihydrochloride", "active_ingredients": [{"name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA203646", "marketing_category": "ANDA", "marketing_start_date": "20140909", "listing_expiration_date": "20261231"}