Prescription drug · ANDA
Ibandronate Sodium NDC 60505-6097
Ibandronate sodium 3 mg/3mL · Injection · Intravenous · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-6097-0 | 60505609700 | 1 SYRINGE, GLASS in 1 CARTON (60505-6097-0) / 3 mL in 1 SYRINGE, GLASSMarketed from Jan 13, 2016 |
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)
- Ibandronate Sodium
- Generic name (nonproprietary)
- ibandronate sodium
- Active ingredients
- Ibandronate sodium — 3 mg/3mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Apotex Corp.NDC labeler code 60505
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204222
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)
- Identifiers
- Product ID 60505-6097_63d90e35-b379-2511-e5fd-b75c1d1d5ddeSPL ID 63d90e35-b379-2511-e5fd-b75c1d1d5ddeSPL set ID 9fad4982-95af-d711-f50a-867311835143RxCUI 904952UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N460505609700followed by a unit qualifier and the quantityPackage 60505-6097-00. 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)
Ibandronate sodium injection is a bisphosphonate indicated for the treatment of osteoporosis in postmenopausal women. ( 1.1 ) 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 ( 1.2 ) 1.1 Treatment of Postmenopausal Osteoporosis Ibandronate sodium Injection is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, ibandronate sodium injection increases bone mineral density (BMD) and reduces the incidence of vertebral fractures [see Clinical Studies (14) ] . 1.2 Important Limitations of Use The safety and effectiveness of iba…
Excerpt only. Read the full label for complete information.
About NDC 60505-6097
- What is NDC 60505-6097?
- 60505-6097 is the product NDC for Ibandronate Sodium, Ibandronate sodium 3 mg/3mL injection, listed with the FDA by Apotex Corp.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ibandronate Sodium.
- What is the active ingredient?
- Ibandronate sodium.
- Who is the labeler?
- Apotex Corp., NDC labeler code 60505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ibandronate Sodium?
- 8 other product NDCs are listed under this name. See all Ibandronate Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ibandronate Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ibandronate Sodium | Ibandronate sodium 150 mg/1 | TabletOral | Bionpharma Inc. | 69452-378 | 69452-0378-74 |
| Ibandronate Sodium | Ibandronate sodium 150 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-150 | 33342-0150-5233342-0150-53 |
| Ibandronate Sodium | Ibandronate sodium 150 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-237 | 65862-0237-03 |
| Ibandronate Sodium | Ibandronate sodium 3 mg/3mL | Injection, SolutionIntravenous | Eugia US LLC | 55150-191 | 55150-0191-83 |
| Ibandronate Sodium | Ibandronate sodium 3 mg/3mL | Injection, SolutionIntravenous | Sun Pharmaceutical Industries, Inc. | 62756-218 | 62756-0218-40 |
| Ibandronate sodium | Ibandronate sodium 150 mg/1 | TabletOral | A-S Medication Solutions | 50090-7654 | 50090-7654-00 |
| Ibandronate sodium | Ibandronate sodium 150 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-575 | 55111-0575-0355111-0575-43 |
| Ibandronate Sodium | Ibandronate sodium 150 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-643 | 60429-0643-73 |