Etyqa NDC 59651-425

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-425Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0425Add 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
59651-425-28	59651042528	1 BLISTER PACK in 1 CARTON (59651-425-28) / 28 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 30, 2023
59651-425-87	59651042587	1 POUCH in 1 CARTON (59651-425-87) / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 30, 2023

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): Etyqa
Generic name (nonproprietary): estradiol and norethindrone acetate
Active ingredients: Estradiol — .5 mg/1Norethindrone acetate — .1 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214729
Marketing start: Jun 30, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
Identifiers: Product ID 59651-425_50c8c596-e201-4370-8487-421925c60b4eSPL ID 50c8c596-e201-4370-8487-421925c60b4eSPL set ID afbc2a33-5eb2-4f01-91e9-07d8050da6ceRxCUI 1359123, 1359124, 1359126, 1359127, 2642136, 2642137UNII 9S44LIC7OJ, 4TI98Z838E
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

N459651042528 followed by a unit qualifier and the quantity

Package 59651-0425-28. 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 Mar 1, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Etyqa is indicated for: Etyqa is an estrogen and progestin combination indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause ( 1.2 ) Limitations of Use: When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. Prevention of Postmenopausal Osteoporosis ( 1.3 ) Limitations of Use: When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 214729

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

FDA NDC Directory listings under ANDA 214729
Product	Strength	Form · route	Labeler	Product NDC
Etyqaestradiol and norethindrone acetate	Estradiol 1 mg/1; Norethindrone acetate .5 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-424