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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
- ndc116254210105480 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
Other records sharing ATC code R06AA08.
- 🇺🇸Carbinoxamine MaleateBluCrest Pharmaceuticals, LLC
- 🇺🇸Carbinoxamine MaleateTRIPOINT THERAPEUTICS, LLC
- 🇺🇸Carbinoxamine MaleateGenus Lifesciences Inc.
- 🇺🇸Carbinoxamine MaleateBiocomp Pharma, Inc.
- 🇺🇸Carbinoxamine MaleateGenus Lifesciences Inc.
- 🇺🇸CARBINOXAMINE MALEATELeading Pharma, LLC
- 🇺🇸CARBZAHIPG Pharmaceuticals, inc.
- 🇺🇸KarbinalAytu Therapeutics, LLC
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