Prescription drug · ANDA
Ibandronate Sodium NDC 69452-378
Ibandronate sodium 150 mg/1 · Tablet · Oral · Bionpharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69452-378-74 | 6945203787469452037874 | 1 BLISTER PACK in 1 CARTON (69452-378-74) / 3 TABLET in 1 BLISTER PACKMarketed from May 26, 2023 |
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
- Labeler
- Bionpharma Inc.NDC labeler code 69452
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078998
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)
- Identifiers
- Product ID 69452-378_55845f3d-9d8b-4426-96ea-e73438e380d1SPL ID 55845f3d-9d8b-4426-96ea-e73438e380d1SPL set ID 6ca94cce-a2bb-421f-bd8f-6b14bc2bd985RxCUI 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
N469452037874followed by a unit qualifier and the quantityPackage 69452-0378-74. 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 Tablets are a bisphosphonate indicated for the treatment and prevention of post-menopausal 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 The optimal duration of use has not been determined. The safety and effectiveness…
Excerpt only. Read the full label for complete information.
About NDC 69452-378
- What is NDC 69452-378?
- 69452-378 is the product NDC for Ibandronate Sodium, Ibandronate sodium 150 mg/1 tablet, listed with the FDA by Bionpharma 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?
- Bionpharma Inc., NDC labeler code 69452. 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 | 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 | 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 |
| Ibandronate Sodium | Ibandronate sodium 150 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-643 | 60429-0643-73 |