esterified estrogens and methyltestosterone

Generic: esterified estrogens and methyltestosterone

Labeler: amneal pharmaceuticals of new york 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 and methyltestosterone
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-078
Product ID 53746-078_c2c9cf77-504d-4d7c-8899-c3cb6f76c545
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2010-09-22

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 53746078
Hyphenated Format 53746-078

Supplemental Identifiers

RxCUI
197670 238006
UPC
0353746078018 0353746077011
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 and 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 (53746-078-01)
source: ndc

Packages (1)

53746-078-01 100 TABLET in 1 BOTTLE (53746-078-01)

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": "c2c9cf77-504d-4d7c-8899-c3cb6f76c545", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "upc": ["0353746078018", "0353746077011"], "unii": ["V9EFU16ZIF", "3ASP8Q3768"], "rxcui": ["197670", "238006"], "spl_set_id": ["316650b7-5770-4f1a-867d-68a72c60c8f2"], "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 TABLET in 1 BOTTLE (53746-078-01)", "package_ndc": "53746-078-01", "marketing_start_date": "20100922"}], "brand_name": "Esterified Estrogens and Methyltestosterone", "product_id": "53746-078_c2c9cf77-504d-4d7c-8899-c3cb6f76c545", "dosage_form": "TABLET", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "53746-078", "dea_schedule": "CIII", "generic_name": "Esterified Estrogens and Methyltestosterone", "labeler_name": "Amneal Pharmaceuticals of New York 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": "20100922", "listing_expiration_date": "20261231"}