Prescription drug · ANDA
Raloxifene Hydrochloride (Raloxifene) NDC 71610-524
Raloxifene hydrochloride 60 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-524-60 | 7161005246071610052460 | 90 TABLET in 1 BOTTLE (71610-524-60)Marketed from Feb 3, 2021 |
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
- Active ingredients
- Raloxifene hydrochloride — 60 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- 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 71610-524_4dfb7a20-54ea-4e48-9f0d-03099593073fSPL ID 4dfb7a20-54ea-4e48-9f0d-03099593073fSPL set ID 53a2db10-4af8-4032-b598-b7c7a0969801RxCUI 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
N471610052460followed by a unit qualifier and the quantityPackage 71610-0524-60. 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.
About NDC 71610-524
- What is NDC 71610-524?
- 71610-524 is the product NDC for Raloxifene Hydrochloride (raloxifene), Raloxifene hydrochloride 60 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Raloxifene Hydrochloride (Raloxifene).
- What is the active ingredient?
- Raloxifene hydrochloride.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Raloxifene Hydrochloride?
- 19 other product NDCs are listed under this name. See all Raloxifene Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Raloxifene Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Raloxifene Hydrochloride | Raloxifene hydrochloride 60 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-694 | 50268-0694-15 |
| Raloxifene hydrochloride | Raloxifene hydrochloride 60 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-6177 | 50090-6177-01 |
| Raloxifene hydrochloride | Raloxifene hydrochloride 60 mg/1 | Tablet, CoatedOral | Cadila Pharmaceuticals Limited | 71209-082 | 71209-0082-0171209-0082-0571209-0082-11+1 more |
| Raloxifene hydrochloride | Raloxifene hydrochloride 60 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 72162-2418 | 72162-2418-0072162-2418-0172162-2418-03 |
| Raloxifene hydrochloride | Raloxifene hydrochloride 60 mg/1 | Tablet, CoatedOral | Modavar Pharmaceuticals LLC | 72241-010 | 72241-0010-0572241-0010-1172241-0010-13+1 more |
| Raloxifene Hydrochlorideraloxifene | Raloxifene hydrochloride 60 mg/1 | TabletOral | American Health Packaging | 60687-266 | 60687-0266-21 |
| Raloxifene hydrochloride | Raloxifene hydrochloride 60 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6902 | 00904-6902-04 |
| Raloxifene hydrochloride | Raloxifene hydrochloride 60 mg/1 | Tablet, Film coatedOral | Dr.Reddys Laboratories Inc | 43598-505 | 43598-0505-0143598-0505-1043598-0505-30 |
| Raloxifene hydrochloride | Raloxifene hydrochloride 60 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals Inc | 50228-306 | 50228-0306-2050228-0306-30 |
| Raloxifene hydrochloride | Raloxifene hydrochloride 60 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1460 | 71335-1460-0171335-1460-02 |
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 | American Health Packaging | 60687-266 |
| Raloxifene Hydrochlorideraloxifene | Raloxifene hydrochloride 60 mg/1 | TabletOral | Cipla USA Inc. | 69097-825 |
| Raloxifene Hydrochloride | Raloxifene hydrochloride 60 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals, Inc. | 76282-256 |