Zoledronic Acid NDC 68083-615

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-615Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0615Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
68083-615-01	68083061501	1 VIAL, GLASS in 1 CARTON (68083-615-01) / 5 mL in 1 VIAL, GLASSMarketed from Nov 8, 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: Gland Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202930
Marketing start: Nov 8, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Diphosphonates (Chemical structure)
Identifiers: Product ID 68083-615_c08f4eee-1566-4493-83f7-48fa1319a234SPL ID c08f4eee-1566-4493-83f7-48fa1319a234SPL set ID 7a5e8962-7c4b-40bb-ad69-0c3edb0338afRxCUI 351114UNII 6XC1PAD3KFUPC 0368083615017, 0368083116019
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.

How CPT relates to drug billing

NDC on a medical claim

N468083061501 followed by a unit qualifier and the quantity

Package 68083-0615-01. 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 Nov 15, 2023.

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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202930

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 202930
Product	Strength	Form · route	Labeler	Product NDC
Zoledronic Acid	Zoledronic acid 4 mg/5mL	Injection, Solution, ConcentrateIntravenous	Gland Pharma Limited	68083-116
Zoledronic Acid	Zoledronic acid 4 mg/5mL	Injection, Solution, ConcentrateIntravenous	BPI Labs LLC	54288-183