FDA.reportPublic FDA data

Esterified Estrogens and Methyltestosterone

Product NDC
84346-450
11-digit product format
843460450
Labeler code
84346
Product ID
84346-450_df296524-e3fe-45f7-b653-2f9a0b0efd9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esterified Estrogens, Methyltestosterone
Dosage form
TABLET
Route
ORAL
Labeler
STATUS PROJECTS PRIVATE LIMITED
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-04-20
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
84346-450-01Esterified Estrogens and Methyltestosterone100 in 1 BOTTLETABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84346-450ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE (ESTERIFIED ESTROGENS, METHYLTESTOSTERONE) TABLET [ANZALP PHARMASOLUTIONS USA LLC]1Current NDC, 1 package rows20240619_289c9515-f17a-4d53-9230-d3aede01bf54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238006estrogens, esterified 0.625 MG / methylTESTOSTERone 1.25 MG Oral TabletPSN289c9515-f17a-4d53-9230-d3aede01bf543
238006estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral TabletSCD289c9515-f17a-4d53-9230-d3aede01bf543
238006EEMT HS Oral TabletSY289c9515-f17a-4d53-9230-d3aede01bf543

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84346-450-0184346045001100 TABLET in 1 BOTTLE (84346-450-01) 100 tablet2024-04-20NoNoHistorical