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United States · US · US:0527-1927_127a6533-e403-48b1-9592-5a90d5cf155e

Methadone Hydrocloride

Orange BookUNIISPLATC N02AC52

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

Identification

ManufacturerLannett Company, Inc.
CountryUS (United States)
ATC codeN02AC52
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0527192736
    1 BOTTLE, PLASTIC in 1 CARTON (0527-1927-36) / 30 mL in 1 BOTTLE, PLASTIC
  • ndc11
    0527192739
    1000 mL in 1 BOTTLE, PLASTIC (0527-1927-39)

Annotations

UNII (FDA Substance ID)
229809935B
METHADONE HYDROCHLORIDE
RxCUI 218337
Orange Book
A212093
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": "0527-1927_127a6533-e403-48b1-9592-5a90d5cf155e",
  "productndc": "0527-1927",
  "dosage_form": "CONCENTRATE",
  "orange_book": {
    "appl_no": "212093",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "Nov 2, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHADONE HYDROCHLORIDE",
  "proprietary_name": "Methadone Hydrocloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA212093",
  "marketing_category": "ANDA",
  "nonproprietary_name": "methadone hydrochloride",
  "start_marketing_date": "20201102",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N02AC52.

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