🇺🇸
United States · US · US:42806-318_43485290-cdfc-4126-a615-c52745fcd68b
Methadone Hydrochloride
Orange BookUNIISPLATC N02AC52
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEpic Pharma, LLC
CountryUS (United States)
ATC codeN02AC52
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc114280631801100 TABLET in 1 BOTTLE (42806-318-01)
Annotations
UNII (FDA Substance ID)
229809935B
METHADONE HYDROCHLORIDE
RxCUI 218337
Orange Book
A090065
AAAA
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": "42806-318_43485290-cdfc-4126-a615-c52745fcd68b",
"productndc": "42806-318",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "090065",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "5MG",
"product_no": "001",
"approval_date": "Aug 18, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10MG",
"product_no": "002",
"approval_date": "Aug 18, 2015"
}
],
"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": "ANDA090065",
"marketing_category": "ANDA",
"nonproprietary_name": "Methadone Hydrochloride",
"start_marketing_date": "20180611",
"active_numerator_strength": "10"
}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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