Raloxifene Hydrochloride (raloxifene) NDC 71610-524

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-524Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0524Add 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
71610-524-60	71610052460	90 TABLET in 1 BOTTLE (71610-524-60)Marketed from Feb 3, 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): Raloxifene Hydrochloride
Generic name (nonproprietary): raloxifene
Active ingredients: Raloxifene hydrochloride — 60 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090842
Marketing start: Jun 29, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Selective Estrogen Receptor Modulators (Mechanism)
Identifiers: Product ID 71610-524_4dfb7a20-54ea-4e48-9f0d-03099593073fSPL ID 4dfb7a20-54ea-4e48-9f0d-03099593073fSPL set ID 53a2db10-4af8-4032-b598-b7c7a0969801RxCUI 1490065UNII 4F86W47BR6
Pharmacologic class: Estrogen Agonist/Antagonist

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

N471610052460 followed by a unit qualifier and the quantity

Package 71610-0524-60. 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 17, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

Raloxifene hydrochloride tablet, USP is an estrogen agonist/ antagonist indicated for: Treatment and prevention of osteoporosis in postmenopausal women. ( 1.1 ) Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. ( 1.2 ). Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. ( 1.3 ) Important Limitations: Raloxifene hydrochloride is not indicated for the treatment of invasive breast cancer, reduction of the risk of recurrence of breast cancer, or reduction of risk of noninvasive breast cancer. ( 1.3 ) 1.1 Treatment and Prevention of Osteoporosis in Postmenopausal Women Raloxifene hydrochloride tablets, …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090842

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

FDA NDC Directory listings under ANDA 090842
Product	Strength	Form · route	Labeler	Product NDC
Raloxifene Hydrochloride	Raloxifene hydrochloride 60 mg/1	Tablet, Film coatedOral	Exelan Pharmaceuticals, Inc.	76282-256
Raloxifene Hydrochlorideraloxifene	Raloxifene hydrochloride 60 mg/1	TabletOral	Cipla USA Inc.	69097-825
Raloxifene Hydrochlorideraloxifene	Raloxifene hydrochloride 60 mg/1	TabletOral	American Health Packaging	60687-266