Raloxifene Hydrochloride NDC 71335-1715

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-1715Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-1715Add 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
71335-1715-1	71335171501	60 TABLET, FILM COATED in 1 BOTTLE (71335-1715-1)Marketed from Oct 2, 2020
71335-1715-2	71335171502	30 TABLET, FILM COATED in 1 BOTTLE (71335-1715-2)Marketed from Dec 29, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 hydrochloride
Active ingredients: Raloxifene hydrochloride — 60 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078193
Marketing start: Mar 28, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Selective Estrogen Receptor Modulators (Mechanism)
Identifiers: Product ID 71335-1715_8f53d830-2fb0-400c-8f03-f81858280782SPL ID 8f53d830-2fb0-400c-8f03-f81858280782SPL set ID 3568ed3c-6afd-4872-a861-93a7873bec9cRxCUI 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

N471335171501 followed by a unit qualifier and the quantity

Package 71335-1715-01. 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 Oct 23, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Raloxifene hydrochloride tablets are 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 tablets are 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 table…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078193

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

FDA NDC Directory listings under ANDA 078193
Product	Strength	Form · route	Labeler	Product NDC
Raloxifene Hydrochloride	Raloxifene hydrochloride 60 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	0093-7290