carbinoxamine maleate

Generic: carbinoxamine maleate

Labeler: genus lifesciences inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbinoxamine maleate
Generic Name carbinoxamine maleate
Labeler genus lifesciences inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

carbinoxamine maleate 4 mg/5mL

Manufacturer
Genus Lifesciences Inc.

Identifiers & Regulatory

Product NDC 64950-243
Product ID 64950-243_12a85f25-d18a-4408-8c66-4e0182287026
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040458
Listing Expiration 2026-12-31
Marketing Start 2023-06-09

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 64950243
Hyphenated Format 64950-243

Supplemental Identifiers

RxCUI
1010696 1012904
UPC
0364950211016
UNII
02O55696WH

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 carbinoxamine maleate (source: ndc)
Generic Name carbinoxamine maleate (source: ndc)
Application Number ANDA040458 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE, PLASTIC (64950-243-04)
  • 473 mL in 1 BOTTLE, PLASTIC (64950-243-16)
source: ndc

Packages (2)

64950-243-04 118 mL in 1 BOTTLE, PLASTIC (64950-243-04) 64950-243-16 473 mL in 1 BOTTLE, PLASTIC (64950-243-16)

Ingredients (1)

carbinoxamine maleate (4 mg/5mL)

Linked Drug Pages (1)

Carbinoxamine Maleate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "12a85f25-d18a-4408-8c66-4e0182287026", "openfda": {"upc": ["0364950211016"], "unii": ["02O55696WH"], "rxcui": ["1010696", "1012904"], "spl_set_id": ["9d11b197-cfdc-4b9b-9935-2920ccb6e522"], "manufacturer_name": ["Genus Lifesciences Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (64950-243-04)", "package_ndc": "64950-243-04", "marketing_start_date": "20230609"}, {"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (64950-243-16)", "package_ndc": "64950-243-16", "marketing_start_date": "20230609"}], "brand_name": "Carbinoxamine Maleate", "product_id": "64950-243_12a85f25-d18a-4408-8c66-4e0182287026", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "64950-243", "generic_name": "Carbinoxamine Maleate", "labeler_name": "Genus Lifesciences Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbinoxamine Maleate", "active_ingredients": [{"name": "CARBINOXAMINE MALEATE", "strength": "4 mg/5mL"}], "application_number": "ANDA040458", "marketing_category": "ANDA", "marketing_start_date": "20230609", "listing_expiration_date": "20261231"}