Prescription drug · NDA
Atelvia (risedronate sodium) NDC 0430-0979
Risedronate sodium hemipentahydrate 30.1 mg/1; Risedronate sodium monohydrate 4.9 mg/1 · Tablet, Delayed release · Oral · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0430-0979-03 | 00430097903 | 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (0430-0979-03)Marketed from Dec 1, 2010 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Atelvia
- 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
- Allergan, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022560
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)Diphosphonates (Chemical structure)
- Identifiers
- Product ID 0430-0979_936662af-4e07-4361-b7ef-760ebfad3e01SPL ID 936662af-4e07-4361-b7ef-760ebfad3e01SPL set ID c8b9ab88-1a26-46c3-80ec-4eaa45202021RxCUI 1020064, 1020065, 1020066UNII 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
N400430097903followed by a unit qualifier and the quantityPackage 00430-0979-03. 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)
Atelvia 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 Atelvia 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 optimal duration of use has not been …
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 |
|---|---|---|---|---|
| Risedronate Sodium | Risedronate sodium hemipentahydrate 30.1 mg/1; Risedronate sodium monohydrate 4.9 mg/1 | Tablet, Delayed releaseOral | Mylan Pharmaceuticals, Inc. | 59762-0407 |