FDA.reportPublic FDA data

Esterified Estrogens and Methyltestosterone

Product NDC
63629-9178
11-digit product format
636299178
Labeler code
63629
Product ID
63629-9178_4f357c14-7824-4583-b97c-125f2d98a9eb
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
.625; 1.25 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, ESTERIFIED.625 mg/1
METHYLTESTOSTERONE1.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3ASP8Q3768, V9EFU16ZIF
Rxcui238006

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
63629-9178-1Esterified Estrogens and Methyltestosterone100 in 1 BOTTLETABLET100103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9178-1EA - Each63629-91787c945d39-8474-4012-915f-88c773c27db012022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9178ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20231025_2157d248-f6f5-4cb4-806d-d2e8eec6a8db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238006estrogens, esterified 0.625 MG / methylTESTOSTERone 1.25 MG Oral TabletPSN2157d248-f6f5-4cb4-806d-d2e8eec6a8db103
238006estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral TabletSCD2157d248-f6f5-4cb4-806d-d2e8eec6a8db103
238006EEMT HS Oral TabletSY2157d248-f6f5-4cb4-806d-d2e8eec6a8db103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9178-163629917801100 TABLET in 1 BOTTLE (63629-9178-1) 100 tablet2022-02-230000-00-00NoNoCurrent