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United States · US · US:44523-825_462c3a74-f82a-4fda-e063-6294a90ab0a7

Carbinoxamine Maleate

Orange BookUNIISPLATC R06AA08

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

Identification

ManufacturerBiocomp Pharma, Inc.
CountryUS (United States)
ATC codeR06AA08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4452382501
    1 BOTTLE in 1 CARTON (44523-825-01) / 100 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
02O55696WH
CARBINOXAMINE MALEATE
RxCUI 91066
Orange Book
A090756
AA
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": "44523-825_462c3a74-f82a-4fda-e063-6294a90ab0a7",
  "productndc": "44523-825",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090756",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "May 27, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CARBINOXAMINE MALEATE",
  "proprietary_name": "Carbinoxamine Maleate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090756",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Carbinoxamine Maleate",
  "start_marketing_date": "20110527",
  "active_numerator_strength": "4"
}

Related drugs

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