Home NDC 69315-283 ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE
Product NDC 69315-283
11-digit product format 693150283
Labeler code 69315
Product ID 69315-283_b0329bda-d477-4eed-815c-1049532e1bb0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ESTERIFIED ESTROGENS, METHYLTESTOSTERONE
Dosage form TABLET
Route ORAL
Labeler Leading Pharmaceuticals, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2022-10-01
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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESTROGENS, ESTERIFIED .625 mg/1 METHYLTESTOSTERONE 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197670 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 69315-283-01 ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE 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 69315-283 ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE (ESTERIFIED ESTROGENS, METHYLTESTOSTERONE) TABLET [LEADING PHARMACEUTICALS, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20240110_823629b9-cfb3-486b-b9aa-8efcfff67f67.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69315-283-01 69315028301 100 TABLET in 1 BOTTLE (69315-283-01) 100 tablet 2022-10-01 0000-00-00 No No Current