Raloxifene hydrochloride NDC 71610-053

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-053Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0053Add 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
71610-053-60	71610005360	90 TABLET, FILM COATED in 1 BOTTLE (71610-053-60)Marketed from Apr 26, 2018

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: Aphena Pharma Solutions - Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206384
Marketing start: Oct 12, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Selective Estrogen Receptor Modulators (Mechanism)
Identifiers: Product ID 71610-053_29e0719a-c1c4-429b-8544-f1efe06c33fdSPL ID 29e0719a-c1c4-429b-8544-f1efe06c33fdSPL set ID 6fd63a06-5bc5-4c50-9b85-b09c89100b80RxCUI 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

N471610005360 followed by a unit qualifier and the quantity

Package 71610-0053-60. 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 Apr 27, 2018. This label includes a boxed warning.

Indications (excerpt from the label)

Raloxifene hydrochloride tablets, 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 tablets, USP 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. 1.1 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 206384

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

FDA NDC Directory listings under ANDA 206384
Product	Strength	Form · route	Labeler	Product NDC
Raloxifene hydrochloride	Raloxifene hydrochloride 60 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1460
Raloxifene hydrochloride	Raloxifene hydrochloride 60 mg/1	Tablet, Film coatedOral	Dr.Reddys Laboratories Inc	43598-505
Raloxifene hydrochloride	Raloxifene hydrochloride 60 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals Inc	50228-306
Raloxifene hydrochloride	Raloxifene hydrochloride 60 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6902