Zoledronic Acid NDC 63323-966

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-966Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0966Add 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
63323-966-00	63323096600	1 VIAL, GLASS in 1 CARTON (63323-966-00) / 100 mL in 1 VIAL, GLASSMarketed from Feb 17, 2017

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 — 5 mg/100mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204217
Marketing start: Feb 17, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Diphosphonates (Chemical structure)
Identifiers: Product ID 63323-966_9fb5ae91-44b4-4b48-aaeb-0a2ba676aa16SPL ID 9fb5ae91-44b4-4b48-aaeb-0a2ba676aa16SPL set ID 16fcf8c9-ef8a-4e93-9ee6-acfadd35a861RxCUI 705824UNII 6XC1PAD3KF
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

N463323096600 followed by a unit qualifier and the quantity

Package 63323-0966-00. 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 Sep 21, 2023.

Indications (excerpt from the label)

Zoledronic acid injection is a bisphosphonate indicated for: •Treatment and prevention of postmenopausal osteoporosis (1.1, 1.2) •Treatment to increase bone mass in men with osteoporosis (1.3) •Treatment and prevention of glucocorticoid-induced osteoporosis (1.4) •Treatment of Paget’s disease of bone in men and women (1.5) Limitations of Use 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 (1.6) 1.1 Treatment of Osteoporosis in Postmenopausal Women Zoledronic acid injection is indicated for treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, diagnosed by bo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204217

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

FDA NDC Directory listings under ANDA 204217
Product	Strength	Form · route	Labeler	Product NDC
Zoledronic Acid	Zoledronic acid 5 mg/100mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-135