Estradiol and Norethindrone Acetate NDC 50742-658

NDC codes

FDA NDC Directory

Product NDC (as listed)50742-658Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50742-0658Add 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
50742-658-28	50742065828	1 BLISTER PACK in 1 CARTON (50742-658-28) / 28 TABLET in 1 BLISTER PACKMarketed from Apr 3, 2019
50742-658-68	50742065868	6 BLISTER PACK in 1 CARTON (50742-658-68) / 28 TABLET in 1 BLISTER PACKMarketed from Apr 3, 2019
50742-658-84	50742065884	3 BLISTER PACK in 1 CARTON (50742-658-84) / 28 TABLET in 1 BLISTER PACKMarketed from Apr 3, 2019

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): Estradiol and Norethindrone Acetate
Generic name (nonproprietary): estradiol and norethindrone acetate
Active ingredients: Estradiol — .5 mg/1Norethindrone acetate — .1 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Ingenus Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210612
Marketing start: Apr 3, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
Identifiers: Product ID 50742-658_b156b1fa-c3f8-42fd-a8e3-e1f9c58e0175SPL ID b156b1fa-c3f8-42fd-a8e3-e1f9c58e0175SPL set ID 50c786d6-91bd-4eea-9455-ff2abc08372fRxCUI 1359123, 1359124, 1359126, 1359127UNII 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

N450742065828 followed by a unit qualifier and the quantity

Package 50742-0658-28. 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 May 29, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Estradiol and norethindrone acetate tablets are 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 est…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210612

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

FDA NDC Directory listings under ANDA 210612
Product	Strength	Form · route	Labeler	Product NDC
Estradiol and Norethindrone Acetate	Estradiol 1 mg/1; Norethindrone acetate .5 mg/1	TabletOral	Ingenus Pharmaceuticals, LLC	50742-657
Estradiol and Norethindrone Acetate	Estradiol .5 mg/1; Norethindrone acetate .1 mg/1	TabletOral	A-S Medication Solutions	50090-8004