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United States · US · US:71335-1360_6f29db41-72f8-4eee-b826-d095449170f8

METHADONE HYDROCHLORIDE

Orange BookUNIISPLATC N02AC52

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN02AC52
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 10

  • ndc11
    7133513600
    168 TABLET in 1 BOTTLE (71335-1360-0)
  • ndc11
    7133513601
    15 TABLET in 1 BOTTLE (71335-1360-1)
  • ndc11
    7133513602
    30 TABLET in 1 BOTTLE (71335-1360-2)
  • ndc11
    7133513603
    90 TABLET in 1 BOTTLE (71335-1360-3)
  • ndc11
    7133513604
    120 TABLET in 1 BOTTLE (71335-1360-4)
  • ndc11
    7133513605
    180 TABLET in 1 BOTTLE (71335-1360-5)
  • ndc11
    7133513606
    60 TABLET in 1 BOTTLE (71335-1360-6)
  • ndc11
    7133513607
    28 TABLET in 1 BOTTLE (71335-1360-7)
  • ndc11
    7133513608
    112 TABLET in 1 BOTTLE (71335-1360-8)
  • ndc11
    7133513609
    56 TABLET in 1 BOTTLE (71335-1360-9)

Annotations

UNII (FDA Substance ID)
229809935B
METHADONE HYDROCHLORIDE
RxCUI 218337
Orange Book
A090635
AAAA
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": "71335-1360_6f29db41-72f8-4eee-b826-d095449170f8",
  "productndc": "71335-1360",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090635",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Nov 25, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Sep 22, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHADONE HYDROCHLORIDE",
  "proprietary_name": "METHADONE HYDROCHLORIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090635",
  "marketing_category": "ANDA",
  "nonproprietary_name": "METHADONE HYDROCHLORIDE",
  "start_marketing_date": "20120116",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N02AC52.

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