Esterified Estrogens and Methyltestosterone

Product NDC
63629-1979
11-digit product format
636291979
Labeler code
63629
Product ID
63629-1979_3043d33a-e1c1-4aa2-90b5-88a1deccecfe
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
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
9d0e3d5e-5fb0-9833-ff7c-640f05e449aeProduct name420230314
aaaf3f1f-0ca7-2c75-a463-4dc624538feeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1979-1Esterified Estrogens and Methyltestosterone100 in 1 BOTTLETABLET100104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1979-1EA - Each63629-197963587034-3ac8-4893-9b56-1a789447cea612021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1979ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20250212_e5b1ce1a-b1dd-47ce-9602-9f8d51ac94da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197670estrogens, esterified 1.25 MG / methylTESTOSTERone 2.5 MG Oral TabletPSNe5b1ce1a-b1dd-47ce-9602-9f8d51ac94da104
197670estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral TabletSCDe5b1ce1a-b1dd-47ce-9602-9f8d51ac94da104
197670EEMT DS Oral TabletSYe5b1ce1a-b1dd-47ce-9602-9f8d51ac94da104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1979-163629197901100 TABLET in 1 BOTTLE (63629-1979-1) 100 tablet2021-01-150000-00-00NoNoCurrent