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United States · US · US:0115-1408_12d97eee-36cf-470e-819a-02ec2218fb94
MethylTESTOSTERone
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 · 3
- ndc110115140801100 CAPSULE in 1 BOTTLE (0115-1408-01)
- ndc1101151408031000 CAPSULE in 1 BOTTLE (0115-1408-03)
- ndc11011514080830 CAPSULE in 1 BOTTLE (0115-1408-08)
Annotations
UNII (FDA Substance ID)
V9EFU16ZIF
METHYLTESTOSTERONE
RxCUI 6904
Orange Book
A204851
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": "0115-1408_12d97eee-36cf-470e-819a-02ec2218fb94",
"productndc": "0115-1408",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "204851",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Sep 21, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": "CIII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METHYLTESTOSTERONE",
"proprietary_name": "MethylTESTOSTERone",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204851",
"marketing_category": "ANDA",
"nonproprietary_name": "METHYLTESTOSTERONE",
"start_marketing_date": "20150921",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code G03BA02.
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