🇺🇸
United States · US · US:63629-2098_de5d18bd-af19-4d7a-bad7-ca5e9a46e126
Methadone Hydrocloride
Orange BookUNIISPLATC N02AC52
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN02AC52
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11636292098130 mL in 1 BOTTLE, PLASTIC (63629-2098-1)
Annotations
UNII (FDA Substance ID)
229809935B
METHADONE HYDROCHLORIDE
RxCUI 218337
Orange Book
A212093
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": "63629-2098_de5d18bd-af19-4d7a-bad7-ca5e9a46e126",
"productndc": "63629-2098",
"dosage_form": "CONCENTRATE",
"orange_book": {
"appl_no": "212093",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10MG/ML",
"product_no": "001",
"approval_date": "Nov 2, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METHADONE HYDROCHLORIDE",
"proprietary_name": "Methadone Hydrocloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA212093",
"marketing_category": "ANDA",
"nonproprietary_name": "methadone hydrochloride",
"start_marketing_date": "20201102",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N02AC52.
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Access this data programmatically
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