raloxifene hydrochloride NDC 68462-393

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-393Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0393Add 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
68462-393-01	68462039301	100 TABLET, FILM COATED in 1 BOTTLE (68462-393-01)Marketed from Mar 22, 2016
68462-393-10	68462039310	1000 TABLET, FILM COATED in 1 BOTTLE (68462-393-10)Marketed from Mar 22, 2016
68462-393-23	68462039323	2000 TABLET, FILM COATED in 1 BOTTLE (68462-393-23)Marketed from Mar 22, 2016
68462-393-30	68462039330	30 TABLET, FILM COATED in 1 BOTTLE (68462-393-30)Marketed from Mar 22, 2016
68462-393-90	68462039390	90 TABLET, FILM COATED in 1 BOTTLE (68462-393-90)Marketed from Mar 22, 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: Glenmark Pharmaceuticals Inc., USA
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204491
Marketing start: Mar 22, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Selective Estrogen Receptor Modulators (Mechanism)
Identifiers: Product ID 68462-393_3681932a-8ad0-4486-ae11-efc2f4b3ee96SPL ID 3681932a-8ad0-4486-ae11-efc2f4b3ee96SPL set ID c05521f8-95d2-44b8-8433-eba539c0f84cRxCUI 1490065UNII 4F86W47BR6UPC 0368462393017
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

N468462039301 followed by a unit qualifier and the quantity

Package 68462-0393-01. 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 May 16, 2024. 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)