Prescription drug · ANDA
Pamidronate Disodium NDC 67457-446
Pamidronate disodium 9 mg/mL · Injection · Intravenous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67457-446-10 | 67457044610 | 1 VIAL in 1 CARTON (67457-446-10) / 10 mL in 1 VIALMarketed from May 10, 2011 |
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)
- Pamidronate Disodium
- Generic name (nonproprietary)
- pamidronate disodium
- Active ingredients
- Pamidronate disodium — 9 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Mylan Institutional LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078520
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)
- Identifiers
- Product ID 67457-446_e3a78042-50cb-49d9-a31e-51d8edddbf4cSPL ID e3a78042-50cb-49d9-a31e-51d8edddbf4cSPL set ID c2ca033e-fa5f-4141-b702-11f8b4303da1RxCUI 1737449, 1737453UNII 8742T8ZQZA
- 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
N467457044610followed by a unit qualifier and the quantityPackage 67457-0446-10. 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)
Pamidronate disodium is a bisphosphonate indicated for the treatment of: • moderate or severe hypercalcemia associated with malignancy, with or without bone metastases ( 1.1 ) • patients with moderate to severe Paget’s disease of bone ( 1.2 ) • osteolytic bone metastases of breast cancer or osteolytic lesions of multiple myeloma, in conjunction with standard antineoplastic therapy ( 1.3 ) Limitations of use Safety and efficacy of pamidronate disodium in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established. ( 1.4 ) 1.1 Hypercalcemia of Malignancy Pamidronate disodium is indicated for the treatment of moderate o…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078520
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 |
|---|---|---|---|---|
| Pamidronate Disodium | Pamidronate disodium 3 mg/mL | InjectionIntravenous | Mylan Institutional LLC | 67457-430 |