🇺🇸
United States · US · US:0406-6221_4e01f70c-6006-4f0d-9fc9-a50788fe3fd1
METHADONE HYDROCHLORIDE
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
- ndc110406622105500 mL in 1 BOTTLE (0406-6221-05)
Annotations
UNII (FDA Substance ID)
229809935B
METHADONE HYDROCHLORIDE
RxCUI 218337
Orange Book
A207537
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": "0406-6221_4e01f70c-6006-4f0d-9fc9-a50788fe3fd1",
"productndc": "0406-6221",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "207537",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "5MG/5ML",
"product_no": "001",
"approval_date": "Oct 2, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10MG/5ML",
"product_no": "002",
"approval_date": "Oct 1, 2019"
}
],
"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": "ANDA207537",
"marketing_category": "ANDA",
"nonproprietary_name": "METHADONE HYDROCHLORIDE",
"start_marketing_date": "20210618",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N02AC52.
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- GBMethadone 100mg capsulesSpecial Order
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- GBMethadone 100mg suppositoriesSpecial Order
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