methyltestosterone

Generic: methyltestosterone

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methyltestosterone
Generic Name methyltestosterone
Labeler amneal pharmaceuticals of new york llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

methyltestosterone 10 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-1408
Product ID 0115-1408_12d97eee-36cf-470e-819a-02ec2218fb94
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204851
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2015-09-21

Pharmacologic Class

Established (EPC)
androgen [epc]
Mechanism of Action
androgen receptor agonists [moa]
Chemical Structure
androstanes [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01151408
Hyphenated Format 0115-1408

Supplemental Identifiers

RxCUI
197975
UPC
0301151408012
UNII
V9EFU16ZIF
NUI
N0000175824 N0000000146 M0001109

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name methyltestosterone (source: ndc)
Generic Name methyltestosterone (source: ndc)
Application Number ANDA204851 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0115-1408-01)
  • 1000 CAPSULE in 1 BOTTLE (0115-1408-03)
  • 30 CAPSULE in 1 BOTTLE (0115-1408-08)
source: ndc

Packages (3)

0115-1408-01 100 CAPSULE in 1 BOTTLE (0115-1408-01) 0115-1408-03 1000 CAPSULE in 1 BOTTLE (0115-1408-03) 0115-1408-08 30 CAPSULE in 1 BOTTLE (0115-1408-08)

Ingredients (1)

methyltestosterone (10 mg/1)

Linked Drug Pages (1)

MethylTESTOSTERone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "12d97eee-36cf-470e-819a-02ec2218fb94", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "upc": ["0301151408012"], "unii": ["V9EFU16ZIF"], "rxcui": ["197975"], "spl_set_id": ["9bed4886-fcd0-4056-be8d-5bb4d15081ce"], "pharm_class_cs": ["Androstanes [CS]"], "pharm_class_epc": ["Androgen [EPC]"], "pharm_class_moa": ["Androgen Receptor Agonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0115-1408-01)", "package_ndc": "0115-1408-01", "marketing_start_date": "20150921"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (0115-1408-03)", "package_ndc": "0115-1408-03", "marketing_start_date": "20150921"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (0115-1408-08)", "package_ndc": "0115-1408-08", "marketing_start_date": "20150921"}], "brand_name": "MethylTESTOSTERone", "product_id": "0115-1408_12d97eee-36cf-470e-819a-02ec2218fb94", "dosage_form": "CAPSULE", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "0115-1408", "dea_schedule": "CIII", "generic_name": "METHYLTESTOSTERONE", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MethylTESTOSTERone", "active_ingredients": [{"name": "METHYLTESTOSTERONE", "strength": "10 mg/1"}], "application_number": "ANDA204851", "marketing_category": "ANDA", "marketing_start_date": "20150921", "listing_expiration_date": "20261231"}