Prescription drug · ANDA
Risedronate Sodium NDC 60505-3165
Risedronate sodium 35 mg/1 · Tablet, Film coated · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-3165-0 | 60505316500 | 1 BLISTER PACK in 1 CARTON (60505-3165-0) / 4 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Nov 30, 2015 | |
| 60505-3165-2 | 60505316502 | 3 BLISTER PACK in 1 CARTON (60505-3165-2) / 4 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Nov 30, 2015 |
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 — 35 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Apotex Corp.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090877
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)
- Identifiers
- Product ID 60505-3165_03750616-5c88-729a-215e-3d796f8ba6a8SPL ID 03750616-5c88-729a-215e-3d796f8ba6a8SPL set ID b90f2e5b-10b8-29a7-0360-31bd0dae0ec2RxCUI 905024, 905028, 905083UNII OFG5EXG60LUPC 0360505309627
- 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
N460505316500followed by a unit qualifier and the quantityPackage 60505-3165-00. 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 .
Indications (excerpt from the label)
Risedronate sodium tablets, USP are 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 tablets, USP are indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate sodium tablets,…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090877
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 150 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3097 |
| Risedronate Sodium | Risedronate sodium 75 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-3096 |
| Risedronate Sodium | Risedronate sodium 35 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-714 |