🇺🇸
United States · US · US:13107-088_73006026-6ba2-49da-824e-a4d05b99a2e7
Methadone Hydrochloride
Orange BookUNIISPLATC N02AC52
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurolife Pharma, LLC
CountryUS (United States)
ATC codeN02AC52
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc111310708801100 TABLET in 1 BOTTLE (13107-088-01)
- ndc11131070883030 TABLET in 1 BOTTLE (13107-088-30)
- ndc1113107088991000 TABLET in 1 BOTTLE (13107-088-99)
Annotations
UNII (FDA Substance ID)
229809935B
METHADONE HYDROCHLORIDE
RxCUI 218337
Orange Book
A203502
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": "13107-088_73006026-6ba2-49da-824e-a4d05b99a2e7",
"productndc": "13107-088",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "203502",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "5MG",
"product_no": "001",
"approval_date": "Aug 31, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10MG",
"product_no": "002",
"approval_date": "Aug 31, 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": "ANDA203502",
"marketing_category": "ANDA",
"nonproprietary_name": "Methadone Hydrochloride",
"start_marketing_date": "20150915",
"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
Access this data programmatically
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