FDA.reportPublic FDA data

Esterified Estrogens and Methyltestosterone

Product NDC
63629-1979
Requested package NDC
63629-1979-1
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 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e5b1ce1a-b1dd-47ce-9602-9f8d51ac94daAvailable on FDA.report

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

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
Esterified Estrogens and MethyltestosteroneESTERIFIED ESTROGENS AND METHYLTESTOSTERONEBryant Ranch Prepacke5b1ce1a-b1dd-47ce-9602-9f8d51ac94da2025-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 63629-1979-1
ndc (product): 63629-1979
ndc11 (package): 63629197901

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