🇺🇸
United States · US · US:0406-8725_eac074c9-ea47-4a82-a4c3-1149c30bf372
METHADOSE
Orange BookUNIISPLATC N02AC52
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSpecGx LLC
CountryUS (United States)
ATC codeN02AC52
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1104068725101000 mL in 1 BOTTLE, PLASTIC (0406-8725-10)
Annotations
UNII (FDA Substance ID)
229809935B
METHADONE HYDROCHLORIDE
RxCUI 218337
Orange Book
N017116
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "229809935B",
"rxcui": "218337",
"inchikey": "FJQXCDYVZAHXNS-UHFFFAOYSA-N",
"display_name": "METHADONE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"808a9d0b-720b-4034-a862-5122ff514608": {
"match": "brand_token",
"title": "METHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [SPECGX LLC]",
"spl_version": "41",
"published_date": "2026-05-01"
}
},
"productid": "0406-8725_eac074c9-ea47-4a82-a4c3-1149c30bf372",
"productndc": "0406-8725",
"dosage_form": "CONCENTRATE",
"orange_book": {
"appl_no": "017116",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AA",
"strength": "10MG/ML",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METHADONE HYDROCHLORIDE",
"proprietary_name": "METHADOSE",
"active_ingred_unit": "mg/mL",
"application_number": "NDA017116",
"marketing_category": "NDA",
"nonproprietary_name": "methadone hydrochloride",
"start_marketing_date": "19730314",
"active_numerator_strength": "10"
}Related drugs
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