Home NDC 84346-450 Esterified Estrogens and Methyltestosterone
Product NDC 84346-450
11-digit product format 843460450
Labeler code 84346
Product ID 84346-450_df296524-e3fe-45f7-b653-2f9a0b0efd9a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Esterified Estrogens, Methyltestosterone
Dosage form TABLET
Route ORAL
Labeler STATUS PROJECTS PRIVATE LIMITED
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2024-04-20
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 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Esterified Estrogens and Methyltestosterone
Listing expiration 2027-12-31 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 3ASP8Q3768 Internal UNII lookup V9EFU16ZIF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 84346-450-01 Esterified Estrogens and Methyltestosterone 100 in 1 BOTTLE TABLET 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84346-450 ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE (ESTERIFIED ESTROGENS, METHYLTESTOSTERONE) TABLET [ANZALP PHARMASOLUTIONS USA LLC] 1 Current NDC, 1 package rows 20240619_289c9515-f17a-4d53-9230-d3aede01bf54.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84346-450-01 84346045001 100 TABLET in 1 BOTTLE (84346-450-01) 100 tablet 2024-04-20 No No Current