Raloxifene hydrochloride NDC 50090-6177

NDC codes

FDA NDC Directory

Product NDC (as listed)50090-6177Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50090-6177Add 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
50090-6177-1	50090617701	90 TABLET, COATED in 1 BOTTLE (50090-6177-1)Marketed from Oct 18, 2022

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, Coated
Route: Oral
Labeler: A-S Medication Solutions
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211324
Marketing start: Dec 30, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Selective Estrogen Receptor Modulators (Mechanism)
Identifiers: Product ID 50090-6177_88a25d54-f913-4a43-9f04-9ab1979ff633SPL ID 88a25d54-f913-4a43-9f04-9ab1979ff633SPL set ID 22a951ee-2ffc-4c60-b681-0f80285153e1RxCUI 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

N450090617701 followed by a unit qualifier and the quantity

Package 50090-6177-01. 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 Nov 1, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Raloxifene hydrochloride 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 is indicated for the tr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211324

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

FDA NDC Directory listings under ANDA 211324
Product	Strength	Form · route	Labeler	Product NDC
Raloxifene hydrochloride	Raloxifene hydrochloride 60 mg/1	Tablet, CoatedOral	Modavar Pharmaceuticals LLC	72241-010
Raloxifene hydrochloride	Raloxifene hydrochloride 60 mg/1	Tablet, CoatedOral	Cadila Pharmaceuticals Limited	71209-082
Raloxifene hydrochloride	Raloxifene hydrochloride 60 mg/1	Tablet, CoatedOral	Bryant Ranch Prepack	72162-2418