Prescription drug · ANDA
Raloxifene Hydrochloride NDC 65862-709
Raloxifene hydrochloride 60 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-709-01 | 65862070901 | 100 TABLET, FILM COATED in 1 BOTTLE (65862-709-01)Marketed from Aug 28, 2015 | |
| 65862-709-03 | 65862070903 | 3 BLISTER PACK in 1 CARTON (65862-709-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-709-10)Marketed from Aug 28, 2015 | |
| 65862-709-22 | 65862070922 | 2000 TABLET, FILM COATED in 1 BOTTLE (65862-709-22)Marketed from Aug 28, 2015 | |
| 65862-709-30 | 65862070930 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-709-30)Marketed from Aug 28, 2015 | |
| 65862-709-99 | 65862070999 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-709-99)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
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204310
- Marketing start
- Listing expires
- Other FDA classes
- Selective Estrogen Receptor Modulators (Mechanism)
- Identifiers
- Product ID 65862-709_161df518-c043-4476-968b-d0268ae03fd5SPL ID 161df518-c043-4476-968b-d0268ae03fd5SPL set ID e8b6cbe0-c1f4-4678-b852-f629a7f6a1b5RxCUI 1490065UNII 4F86W47BR6UPC 0365862709301
- 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
N465862070901followed by a unit qualifier and the quantityPackage 65862-0709-01. 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 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.
Other NDCs under ANDA 204310
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 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 | NorthStar Rx LLC | 16714-213 |
| Raloxifene Hydrochloride | Raloxifene hydrochloride 60 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2059 |