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United States · US · US:62542-101_4cdb19d3-49f4-c257-e063-6294a90aaabd

Carbinoxamine Maleate Extended-Release Oral Suspension

Orange BookUNIISPLATC R06AA08

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerNeos Therapeutics, LP
CountryUS (United States)
ATC codeR06AA08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6254210105
    480 mL in 1 BOTTLE, PLASTIC (62542-101-05)

Annotations

UNII (FDA Substance ID)
02O55696WH
CARBINOXAMINE MALEATE
RxCUI 91066
Orange Book
N022556
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "02O55696WH",
    "rxcui": "91066",
    "inchikey": "GVNWHCVWDRNXAZ-BTJKTKAUSA-N",
    "display_name": "CARBINOXAMINE MALEATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "199f46e5-6288-5627-e063-6294a90ae086": {
      "match": "brand_token",
      "title": "CARBINOXAMINE MALEATE EXTENDED-RELEASE ORAL SUSPENSION (CARBINOXAMINE MALEATE) SUSPENSION, EXTENDED RELEASE [NEOS THERAPEUTICS, LP]",
      "spl_version": "4",
      "published_date": "2026-04-08"
    }
  },
  "productid": "62542-101_4cdb19d3-49f4-c257-e063-6294a90aaabd",
  "productndc": "62542-101",
  "dosage_form": "SUSPENSION, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "022556",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4MG/5ML",
        "product_no": "001",
        "approval_date": "Mar 28, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CARBINOXAMINE MALEATE",
  "proprietary_name": "Carbinoxamine Maleate Extended-Release Oral Suspension",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA022556",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Carbinoxamine Maleate",
  "start_marketing_date": "20240601",
  "active_numerator_strength": "4"
}

Related drugs

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