"72974-415-01" National Drug Code (NDC)

NDC Code	72974-415-01
Package Description	28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-01)
Product NDC	72974-415
Product Type Name	HUMAN PRESCRIPTION DRUG
Proprietary Name	Myfembree
Non-Proprietary Name	Relugolix, Estradiol Hemihydrate, And Norethindrone Acetate
Dosage Form	TABLET, FILM COATED
Usage	ORAL
Start Marketing Date	20210526
Marketing Category Name	NDA
Application Number	NDA214846
Manufacturer	Sumitomo Pharma America, Inc
Substance Name	ESTRADIOL HEMIHYDRATE; NORETHINDRONE ACETATE; RELUGOLIX
Strength	1; .5; 40
Strength Unit	mg/1; mg/1; mg/1
Pharmacy Classes	Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased GnRH Secretion [PE], Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA], Progesterone Congeners [CS], Progestin [EPC]