Esterified Estrogens and Methyltestosterone
Esterified Estrogens and Methyltestosterone Tablets
Approved
Approval ID
3c4cc655-8fcc-416f-867d-707169e7f2a6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 24, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Esterified Estrogens and Methyltestosterone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-9177
Product Classification
G
Generic Name
Esterified Estrogens and Methyltestosterone
Product Specifications
Route of AdministrationORAL
Effective DateApril 26, 2022
FDA Product Classification
INGREDIENTS (14)
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ESTROGENS, ESTERIFIEDActive
Quantity: 1.25 mg in 1 1
Code: 3ASP8Q3768
Classification: ACTIB
METHYLTESTOSTERONEActive
Quantity: 2.5 mg in 1 1
Code: V9EFU16ZIF
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT