🇺🇸
United States · US · US:71335-1360_6f29db41-72f8-4eee-b826-d095449170f8
METHADONE HYDROCHLORIDE
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 · 10
- ndc117133513600168 TABLET in 1 BOTTLE (71335-1360-0)
- ndc11713351360115 TABLET in 1 BOTTLE (71335-1360-1)
- ndc11713351360230 TABLET in 1 BOTTLE (71335-1360-2)
- ndc11713351360390 TABLET in 1 BOTTLE (71335-1360-3)
- ndc117133513604120 TABLET in 1 BOTTLE (71335-1360-4)
- ndc117133513605180 TABLET in 1 BOTTLE (71335-1360-5)
- ndc11713351360660 TABLET in 1 BOTTLE (71335-1360-6)
- ndc11713351360728 TABLET in 1 BOTTLE (71335-1360-7)
- ndc117133513608112 TABLET in 1 BOTTLE (71335-1360-8)
- ndc11713351360956 TABLET in 1 BOTTLE (71335-1360-9)
Annotations
UNII (FDA Substance ID)
229809935B
METHADONE HYDROCHLORIDE
RxCUI 218337
Orange Book
A090635
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": "71335-1360_6f29db41-72f8-4eee-b826-d095449170f8",
"productndc": "71335-1360",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "090635",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10MG",
"product_no": "001",
"approval_date": "Nov 25, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "5MG",
"product_no": "002",
"approval_date": "Sep 22, 2020"
}
],
"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": "ANDA090635",
"marketing_category": "ANDA",
"nonproprietary_name": "METHADONE HYDROCHLORIDE",
"start_marketing_date": "20120116",
"active_numerator_strength": "10"
}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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