Back to search
🇺🇸

United States · US · US:70954-255_987b3eb2-8e19-4ad6-bfdd-670b511d8dd6

Methyltestosterone

Orange BookUNIISPLATC G03BA02

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

Identification

ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG03BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7095425510
    100 CAPSULE in 1 BOTTLE (70954-255-10)

Annotations

UNII (FDA Substance ID)
V9EFU16ZIF
METHYLTESTOSTERONE
RxCUI 6904
Orange Book
A215270
AB
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": {
    "c09c4cde-9f6c-4c4f-9d96-18beb5377564": {
      "match": "brand_token",
      "title": "METHYLTESTOSTERONE CAPSULE [ANI PHARMACEUTICALS, INC.]",
      "spl_version": "2",
      "published_date": "2025-07-21"
    }
  },
  "productid": "70954-255_987b3eb2-8e19-4ad6-bfdd-670b511d8dd6",
  "productndc": "70954-255",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "215270",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Feb 18, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHYLTESTOSTERONE",
  "proprietary_name": "Methyltestosterone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215270",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Methyltestosterone",
  "start_marketing_date": "20220218",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code G03BA02.

Access this data programmatically

Query Methyltestosterone and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.