Prescription drug · ANDA
Risedronate Sodium NDC 71205-714
Risedronate sodium 35 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-714-04 | 71205071404 | 1 BLISTER PACK in 1 CARTON (71205-714-04) / 4 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Nov 10, 2022 |
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)
- Risedronate Sodium
- Generic name (nonproprietary)
- risedronate sodium
- Active ingredients
- Risedronate sodium — 35 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- 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 71205-714_81702f21-3117-49ce-8e9b-2aa2648ba7c3SPL ID 81702f21-3117-49ce-8e9b-2aa2648ba7c3SPL set ID 81702f21-3117-49ce-8e9b-2aa2648ba7c3RxCUI 905024UNII OFG5EXG60LUPC 0371205714048
- 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
N471205071404followed by a unit qualifier and the quantityPackage 71205-0714-04. 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 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 tabl…
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 | Apotex Corp. | 60505-3165 |