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United States · US · US:0054-3555_02c36c8d-ac85-4274-bf54-532c83f57396
Methadone Hydrochloride
Orange BookUNIISPLATC N02AC52
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN02AC52
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110054355563500 mL in 1 BOTTLE (0054-3555-63)
Annotations
UNII (FDA Substance ID)
229809935B
METHADONE HYDROCHLORIDE
RxCUI 218337
Orange Book
A087393
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": "0054-3555_02c36c8d-ac85-4274-bf54-532c83f57396",
"productndc": "0054-3555",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "087393",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AA",
"strength": "5MG/5ML",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"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": "ANDA087393",
"marketing_category": "ANDA",
"nonproprietary_name": "Methadone Hydrochloride",
"start_marketing_date": "19810522",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N02AC52.
- 🇺🇸DISKETSHikma Pharmaceuticals USA Inc.
- GBEptadone 1mg/ml oral solutionDee Pharmaceuticals Ltd
- GBEptadone 5mg/ml oral solutionDee Pharmaceuticals Ltd
- 🇪🇸METASEDIN 10 MG/ML SOLUCIÓN INYECTABLEEsteve Pharmaceuticals S.A.
- 🇪🇸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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