FDA.reportPublic FDA data

Esterified Estrogens and Methyltestosterone

Product NDC
63629-9177
11-digit product format
636299177
Labeler code
63629
Product ID
63629-9177_d75b0017-1cc4-4836-921c-465a3eb97d2e
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
2020-12-15
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

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
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
63629-9177-1Esterified Estrogens and Methyltestosterone100 in 1 BOTTLETABLET100103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9177-1EA - Each63629-9177a0bf790b-7ad0-4efe-a6e0-3acf04c676d812022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9177ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20231025_3c4cc655-8fcc-416f-867d-707169e7f2a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197670estrogens, esterified 1.25 MG / methylTESTOSTERone 2.5 MG Oral TabletPSN3c4cc655-8fcc-416f-867d-707169e7f2a6103
197670estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral TabletSCD3c4cc655-8fcc-416f-867d-707169e7f2a6103
197670EEMT DS Oral TabletSY3c4cc655-8fcc-416f-867d-707169e7f2a6103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9177-163629917701100 TABLET in 1 BOTTLE (63629-9177-1) 100 tablet2022-02-230000-00-00NoNoCurrent