FDA.reportPublic FDA data

Esterified Estrogens and Methyltestosterone

Product NDC
72162-1747
11-digit product format
721621747
Labeler code
72162
Product ID
72162-1747_4bc2aace-7e9a-79e7-e063-6294a90a88c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esterified Estrogens and Methyltestosterone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2010-12-22
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

Additional Listing Data#

Finished product
Yes
Brand name base
Esterified Estrogens and Methyltestosterone
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3ASP8Q3768, V9EFU16ZIF
Rxcui197670

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
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
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
aaaf3f1f-0ca7-2c75-a463-4dc624538feeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1747-1Esterified Estrogens and Methyltestosterone100 in 1 BOTTLETABLET100103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1747-1EA - Each72162-1747b9eaeab5-67fa-461a-aebe-28acda5b5fb012024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1747ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20250305_759907a1-2da7-47df-bf7f-e642f60b998f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197670estrogens, esterified 1.25 MG / methylTESTOSTERone 2.5 MG Oral TabletPSN759907a1-2da7-47df-bf7f-e642f60b998f103
197670estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral TabletSCD759907a1-2da7-47df-bf7f-e642f60b998f103
197670EEMT DS Oral TabletSY759907a1-2da7-47df-bf7f-e642f60b998f103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1747-172162174701100 TABLET in 1 BOTTLE (72162-1747-1) 100 tablet2025-02-04NoNoHistorical