Prescription drug · NDA AUTHORIZED GENERIC
Risedronate Sodium NDC 59762-0406
Risedronate sodium hemipentahydrate 129 mg/1; Risedronate sodium monohydrate 21 mg/1 · Tablet, Film coated · Oral · Mylan Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59762-0406-1 | 59762040601 | 1 TABLET, FILM COATED in 1 DOSE PACK (59762-0406-1)Marketed from Apr 22, 2008 |
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)
- Risedronate Sodium
- Generic name (nonproprietary)
- risedronate sodium
- Active ingredients
- Risedronate sodium hemipentahydrate — 129 mg/1Risedronate sodium monohydrate — 21 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020835
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)Diphosphonates (Chemical structure)
- Identifiers
- Product ID 59762-0406_6015697f-84b2-49c4-b59a-87956261df64SPL ID 6015697f-84b2-49c4-b59a-87956261df64SPL set ID f715718a-407d-4e2a-9834-74a8f1361d03RxCUI 905024, 905028, 905092, 905100UNII HU2YAQ274O, F67L43UT5C
- Pharmacologic class
- Bisphosphonate
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
N459762040601followed by a unit qualifier and the quantityPackage 59762-0406-01. 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 .
Indications (excerpt from the label)
Risedronate Sodium is a bisphosphonate indicated for: Treatment and prevention of postmenopausal osteoporosis ( 1.1 ) Treatment to increase bone mass in men with osteoporosis ( 1.2 ) Treatment and prevention of glucocorticoid-induced osteoporosis ( 1.3 ) Treatment of Paget’s disease ( 1.4 ) Limitations of Use Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. ( 1.5 ) 1.1 Postmenopausal Osteoporosis Risedronate Sodium is indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, Risedronate Sodium reduces the incidence of vertebral f…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020835
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 |
|---|---|---|---|---|
| Actonelrisedronate sodium | Risedronate sodium hemipentahydrate 30.1 mg/1; Risedronate sodium monohydrate 4.9 mg/1 | Tablet, Film coatedOral | Allergan, Inc. | 0430-0472 |
| Actonelrisedronate sodium | Risedronate sodium hemipentahydrate 129 mg/1; Risedronate sodium monohydrate 21 mg/1 | Tablet, Film coatedOral | Allergan, Inc. | 0430-0478 |
| Risedronate Sodium | Risedronate sodium hemipentahydrate 30.1 mg/1; Risedronate sodium monohydrate 4.9 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals, Inc. | 59762-0405 |