Prescription drug · ANDA
Zoledronic Acid NDC 67457-619
Zoledronic acid 5 mg/100mL · Injection, Solution · Intravenous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67457-619-10 | 6745706191067457061910 | 1 VIAL in 1 CARTON (67457-619-10) / 100 mL in 1 VIALMarketed from May 19, 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
- Mylan Institutional LLCNDC labeler code 67457
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203841
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)
- Identifiers
- Product ID 67457-619_1d7e26d1-47f1-45e9-91a5-71f052b6b226SPL ID 1d7e26d1-47f1-45e9-91a5-71f052b6b226SPL set ID 1977d713-4cc7-405e-b4c1-a9a91635eff6RxCUI 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.
- NDC on a medical claim
N467457061910followed by a unit qualifier and the quantityPackage 67457-0619-10. 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)
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, …
Excerpt only. Read the full label for complete information.
About NDC 67457-619
- What is NDC 67457-619?
- 67457-619 is the product NDC for Zoledronic Acid, Zoledronic acid 5 mg/100mL injection, solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zoledronic Acid.
- What is the active ingredient?
- Zoledronic acid.
- Who is the labeler?
- Mylan Institutional LLC, NDC labeler code 67457. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zoledronic Acid?
- 32 other product NDCs are listed under this name. See all Zoledronic Acid NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zoledronic Acid products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| zoledronic acid | Zoledronic acid .04 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-672 | 68083-0672-01 |
| Zoledronic Acid | Zoledronic acid 4 mg/5mL | Injection, Solution, ConcentrateIntravenous | BPI Labs LLC | 54288-183 | 54288-0183-01 |
| Zoledronic Acid | Zoledronic acid 4 mg/5mL | Injection, Solution, ConcentrateIntravenous | Avenacy Inc. | 83634-801 | 83634-0801-05 |
| Zoledronic acid | Zoledronic acid 5 mg/100mL | InjectionIntravenous | BluePoint Laboratories | 68001-611 | 68001-0611-33 |
| Zoledronic acid | Zoledronic acid 4 mg/5mL | Injection, Solution, ConcentrateIntravenous | BluePoint Laboratories | 68001-610 | 68001-0610-25 |
| Zoledronic Acid | Zoledronic acid 4 mg/5mL | Injection, Solution, ConcentrateIntravenous | Gland Pharma Limited | 68083-615 | 68083-0615-01 |
| Zoledronic acid | Zoledronic acid 4 mg/5mL | Injection, Solution, ConcentrateIntravenous | NORTHSTAR RX LLC | 72603-198 | 72603-0198-01 |
| Zoledronic acid | Zoledronic acid 4 mg/5mL | Injection, Solution, ConcentrateIntravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-170 | 23155-0170-31 |
| Zoledronic Acid | Zoledronic acid 4 mg/5mL | Injection, Solution, ConcentrateIntravenous | Dr. Reddy's Laboratories Inc. | 43598-233 | 43598-0233-11 |
| Zoledronic acid | Zoledronic acid 5 mg/100mL | InjectionIntravenous | FOSUN PHARMA USA INC | 72266-152 | 72266-0152-01 |