🇺🇸
United States · US · US:66689-820_ff2d657c-1e8a-4045-95e8-b02ed45a9404
Methadone Hydrochloride
Orange BookUNIISPLATC N02AC52
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerVistaPharm, LLC
CountryUS (United States)
ATC codeN02AC52
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116668982010100 TABLET in 1 BOTTLE (66689-820-10)
Annotations
UNII (FDA Substance ID)
229809935B
METHADONE HYDROCHLORIDE
RxCUI 218337
Orange Book
A040241
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": {
"e72841bf-364b-49b1-8e69-7e26ddcd2657": {
"match": "brand_token",
"title": "METHADONE HYDROCHLORIDE CONCENTRATE [HIKMA PHARMACEUTICALS USA]",
"spl_version": "18",
"published_date": "2026-05-20"
}
},
"productid": "66689-820_ff2d657c-1e8a-4045-95e8-b02ed45a9404",
"productndc": "66689-820",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "040241",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "001",
"approval_date": "May 29, 1998"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "002",
"approval_date": "May 29, 1998"
}
],
"appl_type": "A"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METHADONE HYDROCHLORIDE",
"proprietary_name": "Methadone Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA040241",
"marketing_category": "ANDA",
"nonproprietary_name": "Methadone Hydrochloride",
"start_marketing_date": "20181122",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N02AC52.
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- 🇪🇸METASEDIN 30 mg COMPRIMIDOSEsteve Pharmaceuticals S.A.
- 🇪🇸METASEDIN 40 mg COMPRIMIDOSEsteve Pharmaceuticals S.A.
- 🇪🇸METASEDIN 5 mg COMPRIMIDOSEsteve Pharmaceuticals S.A.
- GBMethadone 1.67mg/5ml oral solutionSpecial Order
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