Prescription drug · NDA
Myfembree NDC 72974-415
relugolix, estradiol hemihydrate, and norethindrone acetate · Relugolix 40 mg/1 + 2 more ingredients · Tablet, Film coated · Oral · Sumitomo Pharma America, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72974-415-01 | 72974041501 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-01)Marketed from May 26, 2021 | |
| 72974-415-99 | 72974041599 | 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-99)Marketed from Jul 7, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Myfembree
- Generic name (nonproprietary)
- relugolix, estradiol hemihydrate, and norethindrone acetate
- Active ingredients
- Relugolix — 40 mg/1Estradiol hemihydrate — 1 mg/1Norethindrone acetate — .5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sumitomo Pharma America, Inc
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214846
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 3A Inducers (Mechanism)Decreased GnRH Secretion (Physiologic effect)Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)Gonadotropin Releasing Hormone Receptor Antagonists (Mechanism)P-Glycoprotein Inhibitors (Mechanism)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 72974-415_d0b51ef8-0118-4b78-a83f-73338d6dab9bSPL ID d0b51ef8-0118-4b78-a83f-73338d6dab9bSPL set ID fc3feb73-cc84-43a8-aa32-b262460495e8RxCUI 2556799, 2556800UNII P76B05O5V6, CXY7B3Q98Z, 9S44LIC7OJUPC 0372974415013
- Pharmacologic class
- Estrogen; Gonadotropin Releasing Hormone Receptor Antagonist; Progestin
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N472974041501followed by a unit qualifier and the quantityPackage 72974-0415-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
MYFEMBREE is a combination of relugolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, estradiol, an estrogen, and norethindrone acetate, a progestin, indicated in premenopausal women for the: management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids). ( 1.1 , 14.1 ) management of moderate to severe pain associated with endometriosis. ( 1.2 , 14.2 ) Limitations of Use Use of MYFEMBREE should be limited to 24 months due to the risk of continued bone loss which may not be reversible. ( 1.3 , 5.2 , 6 ) 1.1 Heavy Menstrual Bleeding Associated with Uterine Leiomyomas MYFEMBREE is indicated for the management of heavy menstrual bleeding associated with uter…
Excerpt only. Read the full label for complete information.