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United States · US · US:23594-101_4cd73883-efb6-9773-e063-6394a90a8285
Karbinal
Orange BookUNIISPLATC R06AA08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAytu Therapeutics, LLC
CountryUS (United States)
ATC codeR06AA08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1123594101012 BOTTLE, PLASTIC in 1 CARTON (23594-101-01) / 30 mL in 1 BOTTLE, PLASTIC
- ndc112359410105480 mL in 1 BOTTLE, PLASTIC (23594-101-05)
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": {
"c40b3f4e-2d71-41a1-a1fc-f64f38724879": {
"match": "brand_token",
"title": "KARBINAL ER (CARBINOXAMINE MALEATE) SUSPENSION, EXTENDED RELEASE [AYTU THERAPEUTICS, LLC]",
"spl_version": "15",
"published_date": "2026-03-18"
}
},
"productid": "23594-101_4cd73883-efb6-9773-e063-6394a90a8285",
"productndc": "23594-101",
"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": "Karbinal",
"active_ingred_unit": "mg/5mL",
"application_number": "NDA022556",
"marketing_category": "NDA",
"nonproprietary_name": "Carbinoxamine Maleate",
"start_marketing_date": "20140103",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code R06AA08.
- 🇺🇸Carbinoxamine MaleateGenus Lifesciences Inc.
- 🇺🇸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.
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