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United States · US · US:0054-4538_5d09b929-38f0-4c89-8bf5-31427a5cd393
DISKETS
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
- ndc110054453825100 TABLET in 1 BOTTLE, PLASTIC (0054-4538-25)
Annotations
UNII (FDA Substance ID)
229809935B
METHADONE HYDROCHLORIDE
RxCUI 218337
Orange Book
N017058
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": {
"e6af84de-cbfc-4a3b-bd73-6bcf77337168": {
"match": "brand_token",
"title": "DISKETS (METHADONE HYDROCHLORIDE) TABLET [HIKMA PHARMACEUTICALS USA INC.]",
"spl_version": "19",
"published_date": "2026-04-17"
}
},
"productid": "0054-4538_5d09b929-38f0-4c89-8bf5-31427a5cd393",
"productndc": "0054-4538",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "017058",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AA",
"strength": "40MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METHADONE HYDROCHLORIDE",
"proprietary_name": "DISKETS",
"active_ingred_unit": "mg/1",
"application_number": "NDA017058",
"marketing_category": "NDA",
"nonproprietary_name": "Methadone Hydrochloride",
"start_marketing_date": "19730314",
"active_numerator_strength": "40"
}Related drugs
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