NDC codes

FDA NDC Directory
Product NDC (as listed)72974-415Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72974-0415Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
72974-415-01729740415017297404150128 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-01)Marketed from May 26, 2021
72974-415-9972974041599729740415997 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, IncNDC labeler code 72974
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

N472974041501 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

About NDC 72974-415

What is NDC 72974-415?
72974-415 is the product NDC for Myfembree, Relugolix 40 mg/1 + 2 more ingredients tablet, film coated, listed with the FDA by Sumitomo Pharma America, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Myfembree (Relugolix, estradiol hemihydrate, and norethindrone acetate).
What is the active ingredient?
Relugolix, Estradiol hemihydrate, Norethindrone acetate.
Who is the labeler?
Sumitomo Pharma America, Inc, NDC labeler code 72974. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Myfembree?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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