Prescription drug · ANDA
Raloxifene Hydrochloride NDC 76282-256
Raloxifene hydrochloride 60 mg/1 · Tablet, Film coated · Oral · Exelan Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-256-01 | 76282025601 | 100 TABLET, FILM COATED in 1 BOTTLE (76282-256-01)Marketed from Nov 12, 2014 | |
| 76282-256-05 | 76282025605 | 500 TABLET, FILM COATED in 1 BOTTLE (76282-256-05)Marketed from Nov 12, 2014 | |
| 76282-256-10 | 76282025610 | 1000 TABLET, FILM COATED in 1 BOTTLE (76282-256-10)Marketed from Apr 15, 2015 | |
| 76282-256-30 | 76282025630 | 30 TABLET, FILM COATED in 1 BOTTLE (76282-256-30)Marketed from Nov 12, 2014 | |
| 76282-256-90 | 76282025690 | 90 TABLET, FILM COATED in 1 BOTTLE (76282-256-90)Marketed from Apr 15, 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
- Exelan Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090842
- Marketing start
- Listing expires
- Other FDA classes
- Selective Estrogen Receptor Modulators (Mechanism)
- Identifiers
- Product ID 76282-256_7238f870-72f1-4e67-9c88-5125522971daSPL ID 7238f870-72f1-4e67-9c88-5125522971daSPL set ID 2b94ecf5-d870-4132-b455-d5ee5c9dce56RxCUI 1490065UNII 4F86W47BR6UPC 0376282256306
- 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
N476282025601followed by a unit qualifier and the quantityPackage 76282-0256-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Raloxifene hydrochloride tablet, 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 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 tablets, …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090842
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Raloxifene Hydrochlorideraloxifene | Raloxifene hydrochloride 60 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-524 |
| Raloxifene Hydrochlorideraloxifene | Raloxifene hydrochloride 60 mg/1 | TabletOral | Cipla USA Inc. | 69097-825 |
| Raloxifene Hydrochlorideraloxifene | Raloxifene hydrochloride 60 mg/1 | TabletOral | American Health Packaging | 60687-266 |