Prescription drug · ANDA
risedronate sodium NDC 47335-667
Risedronate sodium hemi-pentahydrate 30 mg/1 · Tablet, Film coated · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-667-08 | 47335066708 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-667-08)Marketed from Nov 30, 2015 | |
| 47335-667-18 | 47335066718 | 1000 TABLET, FILM COATED in 1 BOTTLE (47335-667-18)Marketed from Nov 30, 2015 | |
| 47335-667-83 | 47335066783 | 30 TABLET, FILM COATED in 1 BOTTLE (47335-667-83)Marketed from Nov 30, 2015 | |
| 47335-667-88 | 47335066788 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-667-88)Marketed from Nov 30, 2015 |
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 hemi-pentahydrate — 30 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090886
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)
- Identifiers
- Product ID 47335-667_a9910c38-e099-4f8a-a7e9-a88623be2032SPL ID a9910c38-e099-4f8a-a7e9-a88623be2032SPL set ID e0b5f0ed-ff40-4f0d-bb86-81a7ace9f339RxCUI 905024, 905028, 905032, 905041, 905083, 905092, 905100UNII HU2YAQ274OUPC 0347335727982
- 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
N447335066708followed by a unit qualifier and the quantityPackage 47335-0667-08. 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 tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate sodium tablets reduce the incidenc…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090886
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 hemi-pentahydrate 35 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-668 |
| risedronate sodium | Risedronate sodium hemi-pentahydrate 5 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-666 |
| risedronate sodium | Risedronate sodium hemi-pentahydrate 75 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-727 |
| risedronate sodium | Risedronate sodium hemi-pentahydrate 150 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-928 |