Prescription drug · NDA AUTHORIZED GENERIC
Risedronate Sodium NDC 59762-0407
Risedronate sodium hemipentahydrate 30.1 mg/1; Risedronate sodium monohydrate 4.9 mg/1 · Tablet, Delayed release · Oral · Mylan Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59762-0407-4 | 59762040704 | 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (59762-0407-4)Marketed from Mar 2, 2018 |
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 — 30.1 mg/1Risedronate sodium monohydrate — 4.9 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 022560
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)Diphosphonates (Chemical structure)
- Identifiers
- Product ID 59762-0407_b7e3ea01-4634-467a-b087-3d52ef7af465SPL ID b7e3ea01-4634-467a-b087-3d52ef7af465SPL set ID c89430be-15f1-4b8b-ab7e-738de716ee7dRxCUI 1020064, 1020065UNII 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
N459762040704followed by a unit qualifier and the quantityPackage 59762-0407-04. 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 in a delayed-release formulation and is indicated for treatment of postmenopausal osteoporosis ( 1.1 ) 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 ( 1.2 ) 1.1 Postmenopausal Osteoporosis Risedronate sodium delayed-release is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, risedronate sodium has been shown to reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [ see Clinical Studies (14.1) ] . 1.2 Important Limitations of Use The…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022560
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 |
|---|---|---|---|---|
| Atelviarisedronate sodium | Risedronate sodium hemipentahydrate 30.1 mg/1; Risedronate sodium monohydrate 4.9 mg/1 | Tablet, Delayed releaseOral | Allergan, Inc. | 0430-0979 |