Esterified Estrogens and Methyltestosterone
Esterified Estrogens and Methyltestosterone Tablets, 1.25 mg/2.5 mg Esterified Estrogens and Methyltestosterone Tablets, 0.625 mg/1.25 mg (Half-Strength) CIII
Approved
Approval ID
e5b1ce1a-b1dd-47ce-9602-9f8d51ac94da
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 9, 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
NDC Product Code63629-1979
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateDecember 1, 2017
Generic NameEsterified Estrogens and Methyltestosterone
INGREDIENTS (28)
METHYLTESTOSTERONEActive
Quantity: 2.5 mg in 1 1
Code: V9EFU16ZIF
Classification: ACTIB
ESTROGENS, ESTERIFIEDActive
Quantity: 1.25 mg in 1 1
Code: 3ASP8Q3768
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USF
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT