FDA.reportPublic FDA data

ESTRATEST H.S.

Product NDC
58657-403
11-digit product format
586570403
Labeler code
58657
Product ID
58657-403_41b4c56d-4bd6-f1cf-e063-6394a90a332d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESTERIFIED ESTROGENS, METHYLTESTOSTERONE
Dosage form
TABLET
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-06-15
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 H.S.
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTROGENS, ESTERIFIED.625 mg/1
METHYLTESTOSTERONE1.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV9EFU16ZIF, 3ASP8Q3768
Rxcui197670, 209251, 209253, 238006

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
58657-403-01ESTRATEST H.S.100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-403-01EA - Each58657-40323206688-2a8b-4c77-91cf-4a4e20811e3812024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-403ESTRATEST H.S. (ESTERIFIED ESTROGENS, METHYLTESTOSTERONE) TABLET ESTRATEST F.S. (ESTERIFIED ESTROGENS, METHYLTESTOSTERONE) TABLET [METHOD PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20240617_1ab6a396-b384-7958-e063-6394a90abfdd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209253Estratest F.S. 1.25 MG / 2.5 MG Oral TabletPSN1ab6a396-b384-7958-e063-6394a90abfdd2
209251Estratest H.S. 0.625 MG / 1.25 MG Oral TabletPSN1ab6a396-b384-7958-e063-6394a90abfdd2
238006estrogens, esterified 0.625 MG / methylTESTOSTERone 1.25 MG Oral TabletPSN1ab6a396-b384-7958-e063-6394a90abfdd2
197670estrogens, esterified 1.25 MG / methylTESTOSTERone 2.5 MG Oral TabletPSN1ab6a396-b384-7958-e063-6394a90abfdd2
209251estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral Tablet [Estratest]SBD1ab6a396-b384-7958-e063-6394a90abfdd2
209253estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral Tablet [Estratest]SBD1ab6a396-b384-7958-e063-6394a90abfdd2
238006estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral TabletSCD1ab6a396-b384-7958-e063-6394a90abfdd2
197670estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral TabletSCD1ab6a396-b384-7958-e063-6394a90abfdd2
197670EEMT DS Oral TabletSY1ab6a396-b384-7958-e063-6394a90abfdd2
238006EEMT HS Oral TabletSY1ab6a396-b384-7958-e063-6394a90abfdd2
209253Estratest F.S. 1.25 MG / 2.5 MG Oral TabletSY1ab6a396-b384-7958-e063-6394a90abfdd2
209251Estratest H.S. 0.625 MG / 1.25 MG Oral TabletSY1ab6a396-b384-7958-e063-6394a90abfdd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58657-403-0158657040301100 TABLET in 1 BOTTLE (58657-403-01) 100 tablet2024-06-15NoNoHistorical