myfembree

Generic: relugolix, estradiol hemihydrate, and norethindrone acetate

Labeler: sumitomo pharma america, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name myfembree
Generic Name relugolix, estradiol hemihydrate, and norethindrone acetate
Labeler sumitomo pharma america, inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

estradiol hemihydrate 1 mg/1, norethindrone acetate .5 mg/1, relugolix 40 mg/1

Manufacturer
Sumitomo Pharma America, Inc

Identifiers & Regulatory

Product NDC 72974-415
Product ID 72974-415_d0b51ef8-0118-4b78-a83f-73338d6dab9b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214846
Listing Expiration 2026-12-31
Marketing Start 2021-05-26

Pharmacologic Class

Established (EPC)
gonadotropin releasing hormone receptor antagonist [epc]
Mechanism of Action
gonadotropin releasing hormone receptor antagonists [moa] cytochrome p450 3a inducers [moa] cytochrome p450 2b6 inducers [moa] breast cancer resistance protein inhibitors [moa] p-glycoprotein inhibitors [moa]
Physiologic Effect
decreased gnrh secretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72974415
Hyphenated Format 72974-415

Supplemental Identifiers

RxCUI
2556799 2556800
UPC
0372974415013
UNII
CXY7B3Q98Z 9S44LIC7OJ P76B05O5V6
NUI
N0000175839 N0000175084 N0000008638 N0000190118 N0000187064 N0000190113 N0000185503

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name myfembree (source: ndc)
Generic Name relugolix, estradiol hemihydrate, and norethindrone acetate (source: ndc)
Application Number NDA214846 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
  • .5 mg/1
  • 40 mg/1
source: ndc
Packaging
  • 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-01)
  • 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-99)
source: ndc

Packages (2)

72974-415-01 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-01) 72974-415-99 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-99)

Ingredients (3)

estradiol hemihydrate (1 mg/1) norethindrone acetate (.5 mg/1) relugolix (40 mg/1)

Linked Drug Pages (1)

Myfembree ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d0b51ef8-0118-4b78-a83f-73338d6dab9b", "openfda": {"nui": ["N0000175839", "N0000175084", "N0000008638", "N0000190118", "N0000187064", "N0000190113", "N0000185503"], "upc": ["0372974415013"], "unii": ["CXY7B3Q98Z", "9S44LIC7OJ", "P76B05O5V6"], "rxcui": ["2556799", "2556800"], "spl_set_id": ["fc3feb73-cc84-43a8-aa32-b262460495e8"], "pharm_class_pe": ["Decreased GnRH Secretion [PE]"], "pharm_class_epc": ["Gonadotropin Releasing Hormone Receptor Antagonist [EPC]"], "pharm_class_moa": ["Gonadotropin Releasing Hormone Receptor Antagonists [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Sumitomo Pharma America, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-01)", "package_ndc": "72974-415-01", "marketing_start_date": "20210526"}, {"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-99)", "package_ndc": "72974-415-99", "marketing_start_date": "20210707"}], "brand_name": "Myfembree", "product_id": "72974-415_d0b51ef8-0118-4b78-a83f-73338d6dab9b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["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]"], "product_ndc": "72974-415", "generic_name": "relugolix, estradiol hemihydrate, and norethindrone acetate", "labeler_name": "Sumitomo Pharma America, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Myfembree", "active_ingredients": [{"name": "ESTRADIOL HEMIHYDRATE", "strength": "1 mg/1"}, {"name": "NORETHINDRONE ACETATE", "strength": ".5 mg/1"}, {"name": "RELUGOLIX", "strength": "40 mg/1"}], "application_number": "NDA214846", "marketing_category": "NDA", "marketing_start_date": "20210526", "listing_expiration_date": "20261231"}