FDA.reportPublic FDA data

ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE

Product NDC
72162-2393
11-digit product format
721622393
Labeler code
72162
Product ID
72162-2393_109b1974-468c-4262-8675-ea8c713dc6dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESTERIFIED ESTROGENS, METHYLTESTOSTERONE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-06-15
Substance
ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE
Active strength
1.25; 2.5 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

Additional Listing Data#

Finished product
Yes
Brand name base
ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTROGENS, ESTERIFIED1.25 mg/1
METHYLTESTOSTERONE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3ASP8Q3768, V9EFU16ZIF
Rxcui197670

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9d0e3d5e-5fb0-9833-ff7c-640f05e449aeProduct name420230314
aaaf3f1f-0ca7-2c75-a463-4dc624538feeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2393-1ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE100 in 1 BOTTLETABLET100101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2393-1EA - Each72162-2393bb597a07-b48a-41b4-b71c-6fa59258c65812024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2393ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE (ESTERIFIED ESTROGENS, METHYLTESTOSTERONE) TABLET [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240910_e4ab944f-46ec-4d7c-9932-706c34c5d242.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197670estrogens, esterified 1.25 MG / methylTESTOSTERone 2.5 MG Oral TabletPSNe4ab944f-46ec-4d7c-9932-706c34c5d242101
197670estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral TabletSCDe4ab944f-46ec-4d7c-9932-706c34c5d242101
197670EEMT DS Oral TabletSYe4ab944f-46ec-4d7c-9932-706c34c5d242101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2393-172162239301100 TABLET in 1 BOTTLE (72162-2393-1) 100 tablet2026-03-17NoNoHistorical