ESTRATEST F.S.

Product NDC
72162-2392
11-digit product format
721622392
Labeler code
72162
Product ID
72162-2392_ee7ac505-4b5f-4b42-91cf-6e4641e07257
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
ESTRATEST F.S.
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ASP8Q3768Internal UNII lookup
V9EFU16ZIFInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197670Internal RxNorm lookup
209253Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e9c2b3fb-eadb-49a3-a211-579a33f680c0Available on FDA.report

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
72162-2392-1ESTRATEST F.S.100 in 1 BOTTLETABLET100101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2392-1EA - Each72162-2392367524d9-8fea-4a7a-af2b-bd3ea9094fed12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2392ESTRATEST F.S. (ESTERIFIED ESTROGENS, METHYLTESTOSTERONE) TABLET [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240910_e9c2b3fb-eadb-49a3-a211-579a33f680c0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ESTRATEST F.S.ESTERIFIED ESTROGENS, METHYLTESTOSTERONEBryant Ranch Prepacke9c2b3fb-eadb-49a3-a211-579a33f680c02026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 72162-2392

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209253Estratest F.S. 1.25 MG / 2.5 MG Oral TabletPSNe9c2b3fb-eadb-49a3-a211-579a33f680c0101
197670estrogens, esterified 1.25 MG / methylTESTOSTERone 2.5 MG Oral TabletPSNe9c2b3fb-eadb-49a3-a211-579a33f680c0101
209253estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral Tablet [Estratest]SBDe9c2b3fb-eadb-49a3-a211-579a33f680c0101
197670estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral TabletSCDe9c2b3fb-eadb-49a3-a211-579a33f680c0101
197670EEMT DS Oral TabletSYe9c2b3fb-eadb-49a3-a211-579a33f680c0101
209253Estratest F.S. 1.25 MG / 2.5 MG Oral TabletSYe9c2b3fb-eadb-49a3-a211-579a33f680c0101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2392-172162239201100 TABLET in 1 BOTTLE (72162-2392-1) 100 tablet2026-03-17NoNoCurrent