Prescription drug · ANDA
Risedronate Sodium NDC 60723-041
Risedronate sodium hemi-pentahydrate 35 mg/1 · Tablet, Film coated · Oral · Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60723-041-04 | 60723004104 | 1 BLISTER PACK in 1 CARTON (60723-041-04) / 4 TABLET, FILM COATED in 1 BLISTER PACK (60723-041-01)Marketed from Apr 1, 2019 | |
| 60723-041-12 | 60723004112 | 3 BLISTER PACK in 1 CARTON (60723-041-12) / 4 TABLET, FILM COATED in 1 BLISTER PACK (60723-041-01)Marketed from Apr 1, 2019 |
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 — 35 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207516
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)
- Identifiers
- Product ID 60723-041_460cdef1-681b-7ae4-e063-6294a90a1d55SPL ID 460cdef1-681b-7ae4-e063-6294a90a1d55SPL set ID d60a56cb-ef49-4447-9043-7b6879a20d75RxCUI 905024, 905092, 905100UNII HU2YAQ274O
- 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
N460723004104followed by a unit qualifier and the quantityPackage 60723-0041-04. 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 are 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 reduc…
Excerpt only. Read the full label for complete information.