levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

Labeler: marlex pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocetirizine dihydrochloride
Generic Name levocetirizine dihydrochloride
Labeler marlex pharmaceuticals inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 5 mg/1

Manufacturer
Marlex Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 10135-639
Product ID 10135-639_f380ef7e-eece-412d-b50c-deae2f6098d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202046
Listing Expiration 2026-12-31
Marketing Start 2018-09-01

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 10135639
Hyphenated Format 10135-639

Supplemental Identifiers

RxCUI
855172
UPC
0310135639304 0310135639908
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 ANDA202046 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (10135-639-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (10135-639-90)
source: ndc

Packages (2)

10135-639-30 30 TABLET, FILM COATED in 1 BOTTLE (10135-639-30) 10135-639-90 90 TABLET, FILM COATED in 1 BOTTLE (10135-639-90)

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": "f380ef7e-eece-412d-b50c-deae2f6098d5", "openfda": {"upc": ["0310135639304", "0310135639908"], "unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["f5d8d6a6-6455-430b-8923-090e1ca2ae3b"], "manufacturer_name": ["Marlex Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (10135-639-30)", "package_ndc": "10135-639-30", "marketing_start_date": "20180901"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (10135-639-90)", "package_ndc": "10135-639-90", "marketing_start_date": "20180901"}], "brand_name": "Levocetirizine Dihydrochloride", "product_id": "10135-639_f380ef7e-eece-412d-b50c-deae2f6098d5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "10135-639", "generic_name": "levocetirizine Dihydrochloride", "labeler_name": "Marlex Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levocetirizine Dihydrochloride", "active_ingredients": [{"name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA202046", "marketing_category": "ANDA", "marketing_start_date": "20180901", "listing_expiration_date": "20261231"}