Myfembree
- Product NDC
- 72974-415
- 11-digit product format
- 729740415
- Labeler code
- 72974
- Product ID
- 72974-415_d0b51ef8-0118-4b78-a83f-73338d6dab9b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- relugolix, estradiol hemihydrate, and norethindrone acetate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sumitomo Pharma America, Inc
- Application
- NDA214846
- Marketing category
- NDA
- Marketing start
- 2021-05-26
- Substance
- ESTRADIOL HEMIHYDRATE; NORETHINDRONE ACETATE; RELUGOLIX
- Active strength
- 1; .5; 40 mg/1; mg/1; mg/1
- Pharmacologic 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]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Myfembree
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTRADIOL HEMIHYDRATE | 1 mg/1 |
| NORETHINDRONE ACETATE | .5 mg/1 |
| RELUGOLIX | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CXY7B3Q98Z, 9S44LIC7OJ, P76B05O5V6 |
| Rxcui | 2556799, 2556800 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72974-415-01 | Myfembree | 28 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 28 | | 18 |
| 72974-415-99 | Myfembree | 7 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 7 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72974-415 | MYFEMBREE (RELUGOLIX, ESTRADIOL HEMIHYDRATE, AND NORETHINDRONE ACETATE) TABLET, FILM COATED [SUMITOMO PHARMA AMERICA, INC] | 17 | Current NDC, Legacy NDC, 2 package rows | 20240724_fc3feb73-cc84-43a8-aa32-b262460495e8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72974-415-01 | 72974041501 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-01) | 2021-05-26 | 0000-00-00 | No | No | Current |
| 72974-415-99 | 72974041599 | 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-99) | 2021-07-07 | 0000-00-00 | No | No | Current |