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United States · US · US:0115-7037_d5da1ec5-4a9e-4714-9240-039f802b2c1e

METHITEST

Orange BookUNIISPLATC G03BA02

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

Identification

ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeG03BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0115703701
    100 TABLET in 1 BOTTLE (0115-7037-01)

Annotations

UNII (FDA Substance ID)
V9EFU16ZIF
METHYLTESTOSTERONE
RxCUI 6904
Orange Book
A080767
BP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "V9EFU16ZIF",
    "rxcui": "6904",
    "inchikey": "GCKMFJBGXUYNAG-HLXURNFRSA-N",
    "display_name": "METHYLTESTOSTERONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "77bb4ef4-c10e-4acc-8225-651d003f4561": {
      "match": "brand_token",
      "title": "METHITEST (METHYLTESTOSTERONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]",
      "spl_version": "17",
      "published_date": "2025-06-05"
    }
  },
  "productid": "0115-7037_d5da1ec5-4a9e-4714-9240-039f802b2c1e",
  "productndc": "0115-7037",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "080767",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "BP",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHYLTESTOSTERONE",
  "proprietary_name": "METHITEST",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA080767",
  "marketing_category": "ANDA",
  "nonproprietary_name": "METHYLTESTOSTERONE",
  "start_marketing_date": "19741017",
  "active_numerator_strength": "10"
}

Related drugs

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