Prescription drug · ANDA
Zoledronic acid NDC 72603-198
Zoledronic acid 4 mg/5mL · Injection, Solution, Concentrate · Intravenous · NORTHSTAR RX LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-198-01 | 72603019801 | 1 VIAL, GLASS in 1 CARTON (72603-198-01) / 5 mL in 1 VIAL, GLASSMarketed from Nov 1, 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)
- Zoledronic acid
- Generic name (nonproprietary)
- zoledronic acid
- Active ingredients
- Zoledronic acid — 4 mg/5mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- NORTHSTAR RX LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201783
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)
- Identifiers
- Product ID 72603-198_5499e3f9-5d5d-4eeb-a859-62cc967d468fSPL ID 5499e3f9-5d5d-4eeb-a859-62cc967d468fSPL set ID 3885488c-6b83-421b-afee-61abceb95634RxCUI 351114UNII 6XC1PAD3KFUPC 0372603198010
- 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
N472603019801followed by a unit qualifier and the quantityPackage 72603-0198-01. 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)
Zoledronic acid injection is a bisphosphonate indicated for the treatment of: Hypercalcemia of malignancy. (1.1) Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. (1.2) Limitations of Use : The safety and efficacy of zoledronic acid injection has not been established for use in hyperparathyroidism or non-tumor-related hypercalcemia. 1.1 Hypercalcemia of Malignancy Zoledronic acid injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cCa) of greater…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201783
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 |
|---|---|---|---|---|
| Zoledronic acid | Zoledronic acid 4 mg/5mL | Injection, Solution, ConcentrateIntravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-170 |
| Zoledronic Acid | Zoledronic acid 4 mg/5mL | Injection, Solution, ConcentrateIntravenous | Avenacy Inc. | 83634-801 |
| Zoledronic acid | Zoledronic acid 4 mg/5mL | Injection, Solution, ConcentrateIntravenous | BluePoint Laboratories | 68001-610 |