🇺🇸
United States · US · US:81298-7500_46a3297c-98d2-48ef-a7a9-9776ed80e0bd
Methadone Hydrochloride
Orange BookUNIISPLATC N02AC52
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLong Grove Pharmaceuticals, LLC
CountryUS (United States)
ATC codeN02AC52
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1181298750011 VIAL, GLASS in 1 CARTON (81298-7500-1) / 20 mL in 1 VIAL, GLASS
Annotations
UNII (FDA Substance ID)
229809935B
METHADONE HYDROCHLORIDE
RxCUI 218337
Orange Book
A208306
AP
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": "INTRAVENOUS",
"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": "81298-7500_46a3297c-98d2-48ef-a7a9-9776ed80e0bd",
"productndc": "81298-7500",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "208306",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "10MG/ML",
"product_no": "001",
"approval_date": "Oct 27, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METHADONE HYDROCHLORIDE",
"proprietary_name": "Methadone Hydrochloride",
"active_ingred_unit": "mg/20mL",
"application_number": "ANDA208306",
"marketing_category": "ANDA",
"nonproprietary_name": "Methadone Hydrochloride",
"start_marketing_date": "20250628",
"active_numerator_strength": "200"
}Related drugs
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- GBMethadone 1.67mg/5ml oral solutionSpecial Order
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