Home NDC 53746-077 Esterified Estrogens and Methyltestosterone
Product NDC 53746-077
11-digit product format 537460077
Labeler code 53746
Product ID 53746-077_c2c9cf77-504d-4d7c-8899-c3cb6f76c545
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Esterified Estrogens and Methyltestosterone
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2010-09-22
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53746-077-01 Esterified Estrogens and Methyltestosterone 100 in 1 BOTTLE TABLET 100 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ESTROGENS, CONJUGATED ACTIVE INGREDIENT IU5QR144QX ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] 3 METHYLTESTOSTERONE ACTIVE INGREDIENT V9EFU16ZIF ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] 3 ESTROGENS, CONJUGATED ACTIVE MOIETY IU5QR144QX ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] 3 METHYLTESTOSTERONE ACTIVE MOIETY V9EFU16ZIF ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] 3 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] 3 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53746-077 ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 10 Current NDC, Legacy NDC, 1 package rows 20240101_316650b7-5770-4f1a-867d-68a72c60c8f2.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 53746-077-01 53746007701 100 TABLET in 1 BOTTLE (53746-077-01) 100 tablet 2010-09-22 0000-00-00 No No Current