Prescription drug · ANDA
Ibandronate sodium NDC 55111-575
Ibandronate sodium 150 mg/1 · Tablet · Oral · Dr. Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-575-03 | 55111057503 | 3 BLISTER PACK in 1 CARTON (55111-575-03) / 1 TABLET in 1 BLISTER PACK (55111-575-11)Marketed from Jun 21, 2012 | |
| 55111-575-43 | 55111057543 | 1 BLISTER PACK in 1 CARTON (55111-575-43) / 3 TABLET in 1 BLISTER PACK (55111-575-13)Marketed from Nov 20, 2021 |
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)
- Ibandronate sodium
- Generic name (nonproprietary)
- ibandronate sodium
- Active ingredients
- Ibandronate sodium — 150 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078997
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)
- Identifiers
- Product ID 55111-575_f38ea198-a3dd-aef9-b467-56ecfef1bc39SPL ID f38ea198-a3dd-aef9-b467-56ecfef1bc39SPL set ID f94d9c49-245a-8081-42c4-785113fce498RxCUI 904932UNII J12U072QL0
- 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
N455111057503followed by a unit qualifier and the quantityPackage 55111-0575-03. 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)
Ibandronate sodium tablet is a bisphosphonate indicated for the treatment and prevention of postmenopausal osteoporosis. (1.1) Limitations of Use The 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 Treatment and Prevention of Postmenopausal Osteoporosis Ibandronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. Ibandronate sodium tablets increases bone mineral density (BMD) and reduces the incidence of vertebral fractures. 1.2 Important Limitations of Use The optimal duration of use has not been determined. The safety and effectiv…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078997
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 |
|---|---|---|---|---|
| Ibandronate sodium | Ibandronate sodium 150 mg/1 | TabletOral | A-S Medication Solutions | 50090-7654 |