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
d42eeda8-d810-4481-a403-6a3520b9e69a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 27, 2018
Manufacturers
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
Products 2
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 Code62559-149
Product Classification
G
Generic Name
Esterified Estrogens and Methyltestosterone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2017
FDA Product Classification
INGREDIENTS (28)
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
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USF
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Esterified Estrogens and Methyltestosterone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62559-150
Product Classification
G
Generic Name
Esterified Estrogens and Methyltestosterone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2017
FDA Product Classification
INGREDIENTS (29)
ESTROGENS, ESTERIFIEDActive
Quantity: 0.625 mg in 1 1
Code: 3ASP8Q3768
Classification: ACTIB
METHYLTESTOSTERONEActive
Quantity: 1.25 mg in 1 1
Code: V9EFU16ZIF
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USF
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT