FDA.reportPublic FDA data

ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH

Product NDC
58657-418
11-digit product format
586570418
Labeler code
58657
Product ID
58657-418_30a68873-f9ef-4de8-e063-6394a90ab5a4
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
2025-03-10
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
ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH
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, 238006

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9d0e3d5e-5fb0-9833-ff7c-640f05e449aeProduct name420230314
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
aaaf3f1f-0ca7-2c75-a463-4dc624538feeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-418-01ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-418-01EA - Each58657-418ebdd9c6d-59e8-4ccb-8a42-661b4bc9e21512025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-418ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH (ESTERIFIED ESTROGENS, METHYLTESTOSTERONE) TABLET ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH (ESTERIFIED ESTROGENS, METHYLTESTOSTERONE) TABLET [METHOD PHARMACEUTICALS, LLC]2Current NDC, 1 package rows20250322_2ff36c19-8112-8db3-e063-6394a90a04c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238006estrogens, esterified 0.625 MG / methylTESTOSTERone 1.25 MG Oral TabletPSN2ff36c19-8112-8db3-e063-6394a90a04c62
197670estrogens, esterified 1.25 MG / methylTESTOSTERone 2.5 MG Oral TabletPSN2ff36c19-8112-8db3-e063-6394a90a04c62
238006estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral TabletSCD2ff36c19-8112-8db3-e063-6394a90a04c62
197670estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral TabletSCD2ff36c19-8112-8db3-e063-6394a90a04c62
197670EEMT DS Oral TabletSY2ff36c19-8112-8db3-e063-6394a90a04c62
238006EEMT HS Oral TabletSY2ff36c19-8112-8db3-e063-6394a90a04c62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58657-418-0158657041801100 TABLET in 1 BOTTLE (58657-418-01) 100 tablet2025-03-10NoNoCurrent