carbinoxamine maleate extended-release oral suspension

Generic: carbinoxamine maleate

Labeler: neos therapeutics, lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name carbinoxamine maleate extended-release oral suspension
Generic Name carbinoxamine maleate
Labeler neos therapeutics, lp
Dosage Form SUSPENSION, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

carbinoxamine maleate 4 mg/5mL

Manufacturer
Neos Therapeutics, LP

Identifiers & Regulatory

Product NDC 62542-101
Product ID 62542-101_3e88e362-ac97-23cc-e063-6294a90a4c1b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA022556
Listing Expiration 2026-12-31
Marketing Start 2024-06-01

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 62542101
Hyphenated Format 62542-101

Supplemental Identifiers

RxCUI
1374770
UPC
0362542101059
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 extended-release oral suspension (source: ndc)
Generic Name carbinoxamine maleate (source: ndc)
Application Number NDA022556 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/5mL
source: ndc
Packaging
  • 480 mL in 1 BOTTLE, PLASTIC (62542-101-05)
source: ndc

Packages (1)

62542-101-05 480 mL in 1 BOTTLE, PLASTIC (62542-101-05)

Ingredients (1)

carbinoxamine maleate (4 mg/5mL)

Linked Drug Pages (1)

Carbinoxamine Maleate Extended-Release Oral Suspension ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3e88e362-ac97-23cc-e063-6294a90a4c1b", "openfda": {"upc": ["0362542101059"], "unii": ["02O55696WH"], "rxcui": ["1374770"], "spl_set_id": ["199f46e5-6288-5627-e063-6294a90ae086"], "manufacturer_name": ["Neos Therapeutics, LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "480 mL in 1 BOTTLE, PLASTIC (62542-101-05)", "package_ndc": "62542-101-05", "marketing_start_date": "20240601"}], "brand_name": "Carbinoxamine Maleate Extended-Release Oral Suspension", "product_id": "62542-101_3e88e362-ac97-23cc-e063-6294a90a4c1b", "dosage_form": "SUSPENSION, EXTENDED RELEASE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "62542-101", "generic_name": "Carbinoxamine Maleate", "labeler_name": "Neos Therapeutics, LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbinoxamine Maleate Extended-Release Oral Suspension", "active_ingredients": [{"name": "CARBINOXAMINE MALEATE", "strength": "4 mg/5mL"}], "application_number": "NDA022556", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20240601", "listing_expiration_date": "20261231"}