Estradiol / Norethindrone Acetate NDC 51991-623

NDC codes

FDA NDC Directory

Product NDC (as listed)51991-623Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51991-0623Add 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
51991-623-28	51991062328	1 BLISTER PACK in 1 CARTON (51991-623-28) / 28 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 9, 2011

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 / Norethindrone Acetate
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: Breckenridge Pharmaceutical, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078324
Marketing start: Jun 9, 2011
Listing expires: Dec 31, 2026
Other FDA classes: Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
Identifiers: Product ID 51991-623_d0f8f0e6-e2b1-40ff-8b4b-0ed8a7525689SPL ID d0f8f0e6-e2b1-40ff-8b4b-0ed8a7525689SPL set ID 44125b2f-10ac-435c-bdb4-a29bf8450dbfRxCUI 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

N451991062328 followed by a unit qualifier and the quantity

Package 51991-0623-28. 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 Feb 21, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Estradiol/Norethindrone Acetate Tablets are indicated for: Estradiol/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 c…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078324

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

FDA NDC Directory listings under ANDA 078324
Product	Strength	Form · route	Labeler	Product NDC
Estradiol / Norethindrone Acetateestradiol and norethindrone acetate	Estradiol 1 mg/1; Norethindrone acetate .5 mg/1	Tablet, Film coatedOral	Breckenridge Pharmaceutical, Inc.	51991-474
Estradiol / Norethindrone Acetateestradiol and norethindrone acetate	Estradiol 1 mg/1; Norethindrone acetate .5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-8003