Raloxifene Hydrochloride NDC 16714-213

NDC codes

FDA NDC Directory

Product NDC (as listed)16714-213Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16714-0213Add 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
16714-213-01	16714021301	30 TABLET, FILM COATED in 1 BOTTLE (16714-213-01)Marketed from Aug 28, 2015
16714-213-02	16714021302	100 TABLET, FILM COATED in 1 BOTTLE (16714-213-02)Marketed from Aug 28, 2015
16714-213-03	16714021303	1000 TABLET, FILM COATED in 1 BOTTLE (16714-213-03)Marketed from Aug 28, 2015

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: NorthStar Rx LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204310
Marketing start: Aug 28, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Selective Estrogen Receptor Modulators (Mechanism)
Identifiers: Product ID 16714-213_145e48c3-0ef5-41f7-adc2-ab0a7ca89d87SPL ID 145e48c3-0ef5-41f7-adc2-ab0a7ca89d87SPL set ID 0f7d1f81-374f-4ad5-aea0-2f97abbe1dbfRxCUI 1490065UNII 4F86W47BR6UPC 0316714213019
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

N416714021301 followed by a unit qualifier and the quantity

Package 16714-0213-01. 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 Feb 17, 2024. 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 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 in…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204310

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

FDA NDC Directory listings under ANDA 204310
Product	Strength	Form · route	Labeler	Product NDC
Raloxifene Hydrochloride	Raloxifene hydrochloride 60 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-709
Raloxifene Hydrochloride	Raloxifene hydrochloride 60 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7073
Raloxifene Hydrochloride	Raloxifene hydrochloride 60 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2059