🇺🇸
United States · US · US:66689-711_ba15b069-82f1-4008-8f78-5d657918b3ad
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
- ndc1166689711303 TRAY in 1 CASE (66689-711-30) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (66689-711-05)
Annotations
UNII (FDA Substance ID)
229809935B
METHADONE HYDROCHLORIDE
RxCUI 218337
Orange Book
A090707
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": {
"e72841bf-364b-49b1-8e69-7e26ddcd2657": {
"match": "brand_token",
"title": "METHADONE HYDROCHLORIDE CONCENTRATE [HIKMA PHARMACEUTICALS USA]",
"spl_version": "18",
"published_date": "2026-05-20"
}
},
"productid": "66689-711_ba15b069-82f1-4008-8f78-5d657918b3ad",
"productndc": "66689-711",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "090707",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "5MG/5ML",
"product_no": "001",
"approval_date": "Jun 30, 2010"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG/5ML",
"product_no": "002",
"approval_date": "Jun 30, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METHADONE HYDROCHLORIDE",
"proprietary_name": "Methadone Hydrochloride",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA090707",
"marketing_category": "ANDA",
"nonproprietary_name": "Methadone Hydrochloride",
"start_marketing_date": "20100801",
"active_numerator_strength": "5"
}Related drugs
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- 🇪🇸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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