Raloxifene Hydrochloride NDC 65162-057

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-057Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0057Add 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
65162-057-03	65162005703	30 TABLET, FILM COATED in 1 BOTTLE (65162-057-03)Marketed from Jan 20, 2016
65162-057-09	65162005709	90 TABLET, FILM COATED in 1 BOTTLE (65162-057-09)Marketed from Jan 20, 2016
65162-057-10	65162005710	100 TABLET, FILM COATED in 1 BOTTLE (65162-057-10)Marketed from Jan 20, 2016
65162-057-11	65162005711	1000 TABLET, FILM COATED in 1 BOTTLE (65162-057-11)Marketed from Jan 20, 2016
65162-057-33	65162005733	2000 TABLET, FILM COATED in 1 BOTTLE (65162-057-33)Marketed from Jan 20, 2016
65162-057-50	65162005750	500 TABLET, FILM COATED in 1 BOTTLE (65162-057-50)Marketed from Jan 20, 2016

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 hydrochloride
Active ingredients: Raloxifene hydrochloride — 60 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208206
Marketing start: Jan 20, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Selective Estrogen Receptor Modulators (Mechanism)
Identifiers: Product ID 65162-057_6c80d57b-e265-43cb-a781-6299ea73dccfSPL ID 6c80d57b-e265-43cb-a781-6299ea73dccfSPL set ID 3798c70b-a4b0-4811-9788-e4c9cff47ebeRxCUI 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

N465162005703 followed by a unit qualifier and the quantity

Package 65162-0057-03. 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 Apr 14, 2026. 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 tablets are i…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208206

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

FDA NDC Directory listings under ANDA 208206
Product	Strength	Form · route	Labeler	Product NDC
Raloxifene Hydrochloride	Raloxifene hydrochloride 60 mg/1	Tablet, Film coatedOral	AvPAK	50268-694