FDA.reportPublic FDA data

ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE

Product NDC
69315-284
11-digit product format
693150284
Labeler code
69315
Product ID
69315-284_b0329bda-d477-4eed-815c-1049532e1bb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESTERIFIED ESTROGENS, METHYLTESTOSTERONE
Dosage form
TABLET
Route
ORAL
Labeler
Leading Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-10-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3ASP8Q3768, V9EFU16ZIF
Rxcui197670, 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
69315-284-01ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-284-01EA - Each69315-2843f7dd371-6a07-4306-9318-b32958af3ffe12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-284ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE (ESTERIFIED ESTROGENS, METHYLTESTOSTERONE) TABLET [LEADING PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 1 package rows20240110_823629b9-cfb3-486b-b9aa-8efcfff67f67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238006estrogens, esterified 0.625 MG / methylTESTOSTERone 1.25 MG Oral TabletPSN823629b9-cfb3-486b-b9aa-8efcfff67f672
197670estrogens, esterified 1.25 MG / methylTESTOSTERone 2.5 MG Oral TabletPSN823629b9-cfb3-486b-b9aa-8efcfff67f672
238006estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral TabletSCD823629b9-cfb3-486b-b9aa-8efcfff67f672
197670estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral TabletSCD823629b9-cfb3-486b-b9aa-8efcfff67f672
197670EEMT DS Oral TabletSY823629b9-cfb3-486b-b9aa-8efcfff67f672
238006EEMT HS Oral TabletSY823629b9-cfb3-486b-b9aa-8efcfff67f672

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69315-284-0169315028401100 TABLET in 1 BOTTLE (69315-284-01) 100 tablet2022-10-010000-00-00NoNoCurrent