levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

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

Drug Facts

Product Profile

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

levocetirizine dihydrochloride 5 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-551
Product ID 31722-551_40ccc1d7-149b-e682-e063-6394a90a1d37
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091264
Listing Expiration 2026-12-31
Marketing Start 2012-06-29

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 31722551
Hyphenated Format 31722-551

Supplemental Identifiers

RxCUI
855172
UPC
0331722551304
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 ANDA091264 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (31722-551-05)
  • 1000 TABLET in 1 BOTTLE (31722-551-10)
  • 180 TABLET in 1 BOTTLE (31722-551-18)
  • 30 TABLET in 1 BOTTLE (31722-551-30)
  • 90 TABLET in 1 BOTTLE (31722-551-90)
source: ndc

Packages (5)

31722-551-05 500 TABLET in 1 BOTTLE (31722-551-05) 31722-551-10 1000 TABLET in 1 BOTTLE (31722-551-10) 31722-551-18 180 TABLET in 1 BOTTLE (31722-551-18) 31722-551-30 30 TABLET in 1 BOTTLE (31722-551-30) 31722-551-90 90 TABLET in 1 BOTTLE (31722-551-90)

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": "40ccc1d7-149b-e682-e063-6394a90a1d37", "openfda": {"upc": ["0331722551304"], "unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["dd407f8f-140d-489f-b8c5-f6602d87e247"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (31722-551-05)", "package_ndc": "31722-551-05", "marketing_start_date": "20120629"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (31722-551-10)", "package_ndc": "31722-551-10", "marketing_start_date": "20120629"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (31722-551-18)", "package_ndc": "31722-551-18", "marketing_start_date": "20120629"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (31722-551-30)", "package_ndc": "31722-551-30", "marketing_start_date": "20120629"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (31722-551-90)", "package_ndc": "31722-551-90", "marketing_start_date": "20120629"}], "brand_name": "Levocetirizine Dihydrochloride", "product_id": "31722-551_40ccc1d7-149b-e682-e063-6394a90a1d37", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "31722-551", "generic_name": "Levocetirizine Dihydrochloride", "labeler_name": "Camber Pharmaceuticals, Inc.", "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": "20120629", "listing_expiration_date": "20261231"}