🇺🇸
United States · US · US:51991-002_eec50ad6-d9ae-42df-ae5e-9cd75199148e
Methadone Hydrochloride
Orange BookUNIISPLATC N02AC52
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBreckenridge Pharmaceutical Inc
CountryUS (United States)
ATC codeN02AC52
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1151991002981 VIAL, GLASS in 1 CARTON (51991-002-98) / 20 mL in 1 VIAL, GLASS
Annotations
UNII (FDA Substance ID)
229809935B
METHADONE HYDROCHLORIDE
RxCUI 218337
Orange Book
A218252
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": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"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": "51991-002_eec50ad6-d9ae-42df-ae5e-9cd75199148e",
"productndc": "51991-002",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "218252",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "10MG/ML",
"product_no": "001",
"approval_date": "Dec 16, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METHADONE HYDROCHLORIDE",
"proprietary_name": "Methadone Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA218252",
"marketing_category": "ANDA",
"nonproprietary_name": "Methadone Hydrochloride",
"start_marketing_date": "20241230",
"active_numerator_strength": "10"
}Related drugs
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- GBMethadone 1.67mg/5ml oral solutionSpecial Order
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