Search by Drug Name or NDC
NDC 72974-0415-99 Myfembree 1; .5; 40 mg/1; mg/1; mg/1 Details
Myfembree 1; .5; 40 mg/1; mg/1; mg/1
Myfembree is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sumitomo Pharma America, Inc. The primary component is ESTRADIOL HEMIHYDRATE; NORETHINDRONE ACETATE; RELUGOLIX.
Product Information
| NDC | 72974-0415 |
|---|---|
| Product ID | 72974-415_450384fa-4960-4f5b-8c7d-3ed6360dd1d3 |
| Associated GPIs | 24993503800320 |
| GCN Sequence Number | 082317 |
| GCN Sequence Number Description | relugolix/estradiol/norethindr TABLET 40-1-0.5MG ORAL |
| HIC3 | P1R |
| HIC3 Description | LHRH (GNRH) ANTAGONIST,ESTROGEN AND PROGESTIN COMB |
| GCN | 49699 |
| HICL Sequence Number | 047392 |
| HICL Sequence Number Description | RELUGOLIX/ESTRADIOL/NORETHINDRONE ACETATE |
| Brand/Generic | Brand |
| Proprietary Name | Myfembree |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | relugolix, estradiol hemihydrate, and norethindrone acetate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 1; .5; 40 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | ESTRADIOL HEMIHYDRATE; NORETHINDRONE ACETATE; RELUGOLIX |
| Labeler Name | Sumitomo Pharma America, Inc |
| Pharmaceutical 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 Hor |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA214846 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 72974-0415-99 (72974041599)
| NDC Package Code | 72974-415-99 |
|---|---|
| Billing NDC | 72974041599 |
| Package | 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-99) |
| Marketing Start Date | 2021-07-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |