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 SOLUTION
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 2.5 mg/5mL

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-659
Product ID 31722-659_375cacf2-f8c1-96f1-e063-6394a90ad2df
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210914
Listing Expiration 2026-12-31
Marketing Start 2019-04-01

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 31722659
Hyphenated Format 31722-659

Supplemental Identifiers

RxCUI
855168
UPC
0331722659314
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 ANDA210914 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (31722-659-31) / 148 mL in 1 BOTTLE
source: ndc

Packages (1)

31722-659-31 1 BOTTLE in 1 CARTON (31722-659-31) / 148 mL in 1 BOTTLE

Ingredients (1)

levocetirizine dihydrochloride (2.5 mg/5mL)

Linked Drug Pages (1)

levocetirizine dihydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "375cacf2-f8c1-96f1-e063-6394a90ad2df", "openfda": {"upc": ["0331722659314"], "unii": ["SOD6A38AGA"], "rxcui": ["855168"], "spl_set_id": ["dc8adb01-a7ca-490b-b476-8915f1a2e6db"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (31722-659-31)  / 148 mL in 1 BOTTLE", "package_ndc": "31722-659-31", "marketing_start_date": "20190401"}], "brand_name": "levocetirizine dihydrochloride", "product_id": "31722-659_375cacf2-f8c1-96f1-e063-6394a90ad2df", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "31722-659", "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": "2.5 mg/5mL"}], "application_number": "ANDA210914", "marketing_category": "ANDA", "marketing_start_date": "20190401", "listing_expiration_date": "20261231"}