FDA.reportPublic FDA data

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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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