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United States · US · US:60687-818_3506271d-27f4-2065-e063-6394a90ac386

Methadone Hydrochloride

Orange BookUNIISPLATC N02AC52

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAmerican Health Packaging
CountryUS (United States)
ATC codeN02AC52
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6068781886
    3 TRAY in 1 CASE (60687-818-86) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-818-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-818-40)

Annotations

UNII (FDA Substance ID)
229809935B
METHADONE HYDROCHLORIDE
RxCUI 218337
Orange Book
A087393
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": {
    "e72841bf-364b-49b1-8e69-7e26ddcd2657": {
      "match": "brand_token",
      "title": "METHADONE HYDROCHLORIDE CONCENTRATE [HIKMA PHARMACEUTICALS USA]",
      "spl_version": "18",
      "published_date": "2026-05-20"
    }
  },
  "productid": "60687-818_3506271d-27f4-2065-e063-6394a90ac386",
  "productndc": "60687-818",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "087393",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AA",
        "strength": "5MG/5ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHADONE HYDROCHLORIDE",
  "proprietary_name": "Methadone Hydrochloride",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA087393",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Methadone Hydrochloride",
  "start_marketing_date": "20241216",
  "active_numerator_strength": "5"
}

Related drugs

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