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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

  • ndc11
    0054453825
    100 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

Other records sharing ATC code N02AC52.

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