esterified estrogens and methyltestosterone

Generic: esterified estrogens, methyltestosterone

Labeler: method pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name esterified estrogens and methyltestosterone
Generic Name esterified estrogens, methyltestosterone
Labeler method pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

estrogens, esterified 1.25 mg/1, methyltestosterone 2.5 mg/1

Manufacturer
Method Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 58657-408
Product ID 58657-408_41b4ab92-44f0-da5f-e063-6394a90aa289
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2024-06-15

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 58657408
Hyphenated Format 58657-408

Supplemental Identifiers

RxCUI
197670 238006
UPC
0358657408015
UNII
V9EFU16ZIF 3ASP8Q3768
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 esterified estrogens and methyltestosterone (source: ndc)
Generic Name esterified estrogens, methyltestosterone (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.25 mg/1
  • 2.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (58657-408-01)
source: ndc

Packages (1)

58657-408-01 100 TABLET in 1 BOTTLE (58657-408-01)

Ingredients (2)

estrogens, esterified (1.25 mg/1) methyltestosterone (2.5 mg/1)

Linked Drug Pages (1)

ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "41b4ab92-44f0-da5f-e063-6394a90aa289", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "upc": ["0358657408015"], "unii": ["V9EFU16ZIF", "3ASP8Q3768"], "rxcui": ["197670", "238006"], "spl_set_id": ["1ab68a90-a2a6-b267-e063-6294a90ad751"], "pharm_class_cs": ["Androstanes [CS]"], "pharm_class_epc": ["Androgen [EPC]"], "pharm_class_moa": ["Androgen Receptor Agonists [MoA]"], "manufacturer_name": ["Method Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (58657-408-01)", "package_ndc": "58657-408-01", "marketing_start_date": "20240615"}], "brand_name": "ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE", "product_id": "58657-408_41b4ab92-44f0-da5f-e063-6394a90aa289", "dosage_form": "TABLET", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "58657-408", "dea_schedule": "CIII", "generic_name": "ESTERIFIED ESTROGENS, METHYLTESTOSTERONE", "labeler_name": "Method Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE", "active_ingredients": [{"name": "ESTROGENS, ESTERIFIED", "strength": "1.25 mg/1"}, {"name": "METHYLTESTOSTERONE", "strength": "2.5 mg/1"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20240615", "listing_expiration_date": "20261231"}