Prescription drug · ANDA
Zoledronic Acid NDC 68083-142
Zoledronic acid 4 mg/100mL · Injection · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-142-01 | 68083014201 | 1 VIAL in 1 CARTON (68083-142-01) / 100 mL in 1 VIALMarketed from Jul 5, 2018 |
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/100mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Gland Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205749
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)
- Identifiers
- Product ID 68083-142_a1d17413-5a66-4bc0-8369-c91d360bc2a8SPL ID a1d17413-5a66-4bc0-8369-c91d360bc2a8SPL set ID 1740d7d8-a101-4688-8d8b-beb00559d602RxCUI 1114085UNII 6XC1PAD3KFUPC 0368083142018
- 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
N468083014201followed by a unit qualifier and the quantityPackage 68083-0142-01. 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) Limitation 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 grea…
Excerpt only. Read the full label for complete information.