esterified estrogens and methyltestosterone

Generic: esterified estrogens, methyltestosterone

Labeler: leading 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 leading pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

estrogens, esterified .625 mg/1, methyltestosterone 1.25 mg/1

Manufacturer
Leading Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69315-283
Product ID 69315-283_b0329bda-d477-4eed-815c-1049532e1bb0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2022-10-01

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 69315283
Hyphenated Format 69315-283

Supplemental Identifiers

RxCUI
197670 238006
UPC
0369315284018 0369315283011
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
  • .625 mg/1
  • 1.25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69315-283-01)
source: ndc

Packages (1)

69315-283-01 100 TABLET in 1 BOTTLE (69315-283-01)

Ingredients (2)

estrogens, esterified (.625 mg/1) methyltestosterone (1.25 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": "b0329bda-d477-4eed-815c-1049532e1bb0", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "upc": ["0369315284018", "0369315283011"], "unii": ["V9EFU16ZIF", "3ASP8Q3768"], "rxcui": ["197670", "238006"], "spl_set_id": ["823629b9-cfb3-486b-b9aa-8efcfff67f67"], "pharm_class_cs": ["Androstanes [CS]"], "pharm_class_epc": ["Androgen [EPC]"], "pharm_class_moa": ["Androgen Receptor Agonists [MoA]"], "manufacturer_name": ["Leading Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69315-283-01)", "package_ndc": "69315-283-01", "marketing_start_date": "20221001"}], "brand_name": "ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE", "product_id": "69315-283_b0329bda-d477-4eed-815c-1049532e1bb0", "dosage_form": "TABLET", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "69315-283", "dea_schedule": "CIII", "generic_name": "ESTERIFIED ESTROGENS, METHYLTESTOSTERONE", "labeler_name": "Leading Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE", "active_ingredients": [{"name": "ESTROGENS, ESTERIFIED", "strength": ".625 mg/1"}, {"name": "METHYLTESTOSTERONE", "strength": "1.25 mg/1"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20221001", "listing_expiration_date": "20261231"}