Fyavolv NDC 68180-827

NDC codes

FDA NDC Directory

Product NDC (as listed)68180-827Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68180-0827Add 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 NDC	11-digit (billing)	Package	Copy
68180-827-09	68180082709	90 TABLET, FILM COATED in 1 BOTTLE (68180-827-09)Marketed from Mar 15, 2016
68180-827-73	68180082773	3 POUCH in 1 CARTON (68180-827-73) / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Nov 30, 2020

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): Fyavolv
Generic name (nonproprietary): norethindrone acetate and ethinyl estradiol
Active ingredients: Ethinyl estradiol — .0025 mg/1Norethindrone acetate — .5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Lupin Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204213
Marketing start: Mar 15, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
Identifiers: Product ID 68180-827_42e98704-dee2-481c-849b-e3d9439a7005SPL ID 42e98704-dee2-481c-849b-e3d9439a7005SPL set ID 772c86d7-10a4-48c5-8c19-f8aac68f5ab4RxCUI 1090992, 1251323, 1736654, 1736656UNII 9S44LIC7OJ, 423D2T571UUPC 0368180828099, 0368180827092, 0368180827719, 0368180828716
Pharmacologic class: Estrogen; 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

N468180082709 followed by a unit qualifier and the quantity

Package 68180-0827-09. 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 Jan 6, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Fyavolv is a combination of an estrogen and progestin indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) Prevention of Postmenopausal Osteoporosis ( 1.2 ) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Prevention of Postmenopausal Osteoporosis Limitation of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204213

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 204213
Product	Strength	Form · route	Labeler	Product NDC
Fyavolvnorethindrone acetate and ethinyl estradiol	Ethinyl estradiol .005 mg/1; Norethindrone acetate 1 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-828