Prescription drug · ANDA
Raloxifene hydrochloride NDC 72162-2418
Raloxifene hydrochloride 60 mg/1 · Tablet, Coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2418-0 | 72162241800 | 1000 TABLET, COATED in 1 BOTTLE (72162-2418-0)Marketed from Oct 31, 2024 | |
| 72162-2418-1 | 72162241801 | 100 TABLET, COATED in 1 BOTTLE (72162-2418-1)Marketed from Oct 31, 2024 | |
| 72162-2418-3 | 72162241803 | 30 TABLET, COATED in 1 BOTTLE (72162-2418-3)Marketed from Oct 31, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211324
- Marketing start
- Listing expires
- Other FDA classes
- Selective Estrogen Receptor Modulators (Mechanism)
- Identifiers
- Product ID 72162-2418_098f2903-afc3-4a47-8c22-9cc1ce9d50c3SPL ID 098f2903-afc3-4a47-8c22-9cc1ce9d50c3SPL set ID 7e4bfee5-fefc-4115-9bdb-222eccefca83RxCUI 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
N472162241800followed by a unit qualifier and the quantityPackage 72162-2418-00. 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 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.
Other NDCs under ANDA 211324
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, 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 | Cadila Pharmaceuticals Limited | 71209-082 |