Methamphetamine Hydrochloride

Orange BookUNIISPLATC N06BA03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeN06BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0054038925
100 TABLET in 1 BOTTLE (0054-0389-25)

Annotations

UNII (FDA Substance ID)

997F43Z9CV

METHAMPHETAMINE HYDROCHLORIDE

RxCUI 82044

Orange Book

A203846

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "997F43Z9CV",
    "rxcui": "82044",
    "inchikey": "TWXDDNPPQUTEOV-FVGYRXGTSA-N",
    "display_name": "METHAMPHETAMINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d0905e2c-a02f-ec4f-59a3-6f7ad0acbbf6": {
      "match": "brand_token",
      "title": "METHAMPHETAMINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES INC]",
      "spl_version": "2",
      "published_date": "2025-12-12"
    }
  },
  "productid": "0054-0389_9f3c9287-0615-4d2e-823d-673b33586e06",
  "productndc": "0054-0389",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "203846",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Nov 17, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHAMPHETAMINE HYDROCHLORIDE",
  "proprietary_name": "Methamphetamine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203846",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Methamphetamine Hydrochloride",
  "start_marketing_date": "20161206",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code N06BA03.

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