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United States · US · US:64950-243_12a85f25-d18a-4408-8c66-4e0182287026
Carbinoxamine Maleate
Orange BookUNIISPLATC R06AA08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGenus Lifesciences Inc.
CountryUS (United States)
ATC codeR06AA08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116495024304118 mL in 1 BOTTLE, PLASTIC (64950-243-04)
- ndc116495024316473 mL in 1 BOTTLE, PLASTIC (64950-243-16)
Annotations
UNII (FDA Substance ID)
02O55696WH
CARBINOXAMINE MALEATE
RxCUI 91066
Orange Book
A040458
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": "64950-243_12a85f25-d18a-4408-8c66-4e0182287026",
"productndc": "64950-243",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "040458",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "4MG/5ML",
"product_no": "001",
"approval_date": "Apr 25, 2003"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CARBINOXAMINE MALEATE",
"proprietary_name": "Carbinoxamine Maleate",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA040458",
"marketing_category": "ANDA",
"nonproprietary_name": "Carbinoxamine Maleate",
"start_marketing_date": "20230609",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code R06AA08.
- 🇺🇸Carbinoxamine MaleateTRIPOINT THERAPEUTICS, LLC
- 🇺🇸Carbinoxamine MaleateGenus Lifesciences Inc.
- 🇺🇸Carbinoxamine MaleateBiocomp Pharma, Inc.
- 🇺🇸Carbinoxamine MaleateBluCrest Pharmaceuticals, LLC
- 🇺🇸CARBINOXAMINE MALEATELeading Pharma, LLC
- 🇺🇸Carbinoxamine Maleate Extended-Release Oral SuspensionNeos Therapeutics, LP
- 🇺🇸CARBZAHIPG Pharmaceuticals, inc.
- 🇺🇸KarbinalAytu Therapeutics, LLC
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