Prescription drug · ANDA
Ibandronate Sodium NDC 60429-643
Ibandronate sodium 150 mg/1 · Tablet, Film coated · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60429-643-73 | 60429064373 | 3 BLISTER PACK in 1 PACKAGE (60429-643-73) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Feb 5, 2016 |
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, Film coated
- Route
- Oral
- Labeler
- Golden State Medical Supply, Inc.NDC labeler code 60429
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078948
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)
- Identifiers
- Product ID 60429-643_4b35c1c6-29e6-40f7-e063-6294a90ada88SPL ID 4b35c1c6-29e6-40f7-e063-6294a90ada88SPL set ID 618e1aff-ccbb-4cee-93f1-fe04e33dacb7RxCUI 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
N460429064373followed by a unit qualifier and the quantityPackage 60429-0643-73. 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 increases bone mineral density (BMD) and reduces the incidence of vertebral fractures. 1.2 Important Limitations of Use Theoptimalduration of use has not been determined. The safety and effectivenes…
Excerpt only. Read the full label for complete information.
About NDC 60429-643
- What is NDC 60429-643?
- 60429-643 is the product NDC for Ibandronate Sodium, Ibandronate sodium 150 mg/1 tablet, film coated, listed with the FDA by Golden State Medical Supply, Inc.. 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?
- Golden State Medical Supply, Inc., NDC labeler code 60429. 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?
- 7 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 3 mg/3mL | InjectionIntravenous | Apotex Corp. | 60505-6097 | 60505-6097-00 |
| 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 |