Raloxifene hydrochloride NDC 71209-082

NDC codes

FDA NDC Directory

Product NDC (as listed)71209-082Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71209-0082Add 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
71209-082-01	71209008201	30 TABLET, COATED in 1 BOTTLE (71209-082-01)Marketed from Dec 30, 2017
71209-082-05	71209008205	100 TABLET, COATED in 1 BOTTLE (71209-082-05)Marketed from Dec 30, 2017
71209-082-11	71209008211	1000 TABLET, COATED in 1 BOTTLE (71209-082-11)Marketed from Dec 13, 2021
71209-082-13	71209008213	2000 TABLET, COATED in 1 BOTTLE (71209-082-13)Marketed from Dec 30, 2017

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, Coated
Route: Oral
Labeler: Cadila Pharmaceuticals Limited
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 71209-082_14d4c334-b49d-4479-a91e-20b7276b4ecaSPL ID 14d4c334-b49d-4479-a91e-20b7276b4ecaSPL set ID a46bcc4f-f63d-4200-836d-a653a3c616dbRxCUI 1490065UNII 4F86W47BR6UPC 0371209082112
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

N471209008201 followed by a unit qualifier and the quantity

Package 71209-0082-01. 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 Jan 19, 2022. 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	A-S Medication Solutions	50090-6177
Raloxifene hydrochloride	Raloxifene hydrochloride 60 mg/1	Tablet, CoatedOral	Bryant Ranch Prepack	72162-2418