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United States · US · US:17856-0392_36b0bbb0-eb9e-7547-e063-6394a90a25f4

Methadone Hydrochloride

Orange BookUNIISPLATC N02AC52

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

Identification

ManufacturerATLANTIC BIOLOGICALS CORP.
CountryUS (United States)
ATC codeN02AC52
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    1785603921
    60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0392-1) / .5 mL in 1 SYRINGE
  • ndc11
    1785603923
    72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0392-3) / 2.5 mL in 1 CUP, UNIT-DOSE (17856-0392-4)
  • ndc11
    1785603926
    1 SYRINGE in 1 BAG (17856-0392-6) / .5 mL in 1 SYRINGE
  • ndc11
    1785603927
    5 BOX, UNIT-DOSE in 1 SYRINGE (17856-0392-7) / 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0392-2) / 1 mL in 1 SYRINGE (17856-0392-5)
  • ndc11
    1785603928
    1 SYRINGE in 1 BAG (17856-0392-8) / 1 mL in 1 SYRINGE
  • ndc11
    1785603929
    1 SYRINGE in 1 BAG (17856-0392-9) / 2.5 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)
229809935B
METHADONE HYDROCHLORIDE
RxCUI 218337
Orange Book
A040180
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": "17856-0392_36b0bbb0-eb9e-7547-e063-6394a90a25f4",
  "productndc": "17856-0392",
  "dosage_form": "CONCENTRATE",
  "orange_book": {
    "appl_no": "040180",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "Apr 30, 1998"
      }
    ],
    "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": "ANDA040180",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Methadone Hydrochloride",
  "start_marketing_date": "20190514",
  "active_numerator_strength": "10"
}

Related drugs

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