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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
- ndc117095425510100 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.
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