carbinoxamine maleate

Generic: carbinoxamine maleate

Labeler: biocomp pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbinoxamine maleate
Generic Name carbinoxamine maleate
Labeler biocomp pharma, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

carbinoxamine maleate 4 mg/1

Manufacturer
Biocomp Pharma, Inc.

Identifiers & Regulatory

Product NDC 44523-825
Product ID 44523-825_462c3a74-f82a-4fda-e063-6294a90ab0a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090756
Listing Expiration 2026-12-31
Marketing Start 2011-05-27

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 44523825
Hyphenated Format 44523-825

Supplemental Identifiers

RxCUI
1012904
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 ANDA090756 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (44523-825-01) / 100 TABLET in 1 BOTTLE
source: ndc

Packages (1)

44523-825-01 1 BOTTLE in 1 CARTON (44523-825-01) / 100 TABLET in 1 BOTTLE

Ingredients (1)

carbinoxamine maleate (4 mg/1)

Linked Drug Pages (1)

Carbinoxamine Maleate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "462c3a74-f82a-4fda-e063-6294a90ab0a7", "openfda": {"unii": ["02O55696WH"], "rxcui": ["1012904"], "spl_set_id": ["14266e97-674b-b6a9-37a2-a955f0a01c4f"], "manufacturer_name": ["Biocomp Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (44523-825-01)  / 100 TABLET in 1 BOTTLE", "package_ndc": "44523-825-01", "marketing_start_date": "20210628"}], "brand_name": "Carbinoxamine Maleate", "product_id": "44523-825_462c3a74-f82a-4fda-e063-6294a90ab0a7", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "44523-825", "generic_name": "Carbinoxamine Maleate", "labeler_name": "Biocomp Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbinoxamine Maleate", "active_ingredients": [{"name": "CARBINOXAMINE MALEATE", "strength": "4 mg/1"}], "application_number": "ANDA090756", "marketing_category": "ANDA", "marketing_start_date": "20110527", "listing_expiration_date": "20261231"}