Home NDC 58657-416 Estratest HS
Product NDC 58657-416
11-digit product format 586570416
Labeler code 58657
Product ID 58657-416_30b39516-075b-29f9-e063-6294a90ac30c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Esterified Estrogens and Methyltestosterone
Dosage form TABLET
Route ORAL
Labeler Method Pharmaceuticals
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2025-03-10
Substance ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE
Active strength .625; 1.25 mg/1; mg/1
Pharmacologic classes Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Estratest HS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYLTESTOSTERONE .625 mg/1 ESTROGENS, ESTERIFIED 1.25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V9EFU16ZIF Internal UNII lookup 3ASP8Q3768 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197670 Internal RxNorm lookup 209251 Internal RxNorm lookup 209253 Internal RxNorm lookup 238006 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58657-416-01 Estratest HS 100 in 1 BOTTLE TABLET 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58657-416 ESTRATEST FS (ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE) TABLET ESTRATEST HS (ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE) TABLET [METHOD PHARMACEUTICALS] 2 Current NDC, 1 package rows 20250322_30074e3d-aa36-50c4-e063-6294a90a4d5c.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Estratest HS ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE Method Pharmaceuticals 30074e3d-aa36-50c4-e063-6294a90a4d5c 2025-03-10 Boxed warning, Warnings, Adverse reactions Exact identifier ndc (product): 58657-416
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58657-416-01 58657041601 100 TABLET in 1 BOTTLE (58657-416-01) 100 tablet 2025-03-10 No No Current