Prescription drug · ANDA
Zoledronic acid NDC 68001-611
Zoledronic acid 5 mg/100mL · Injection · Intravenous · BluePoint Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68001-611-33 | 6800106113368001061133 | 1 BAG in 1 CARTON (68001-611-33) / 100 mL in 1 BAGMarketed from Jul 6, 2024 |
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
- Route
- Intravenous
- Labeler
- BluePoint LaboratoriesNDC labeler code 68001
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209578
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)
- Identifiers
- Product ID 68001-611_5b1d2c97-5d37-89d6-e063-6394a90a4402SPL ID 5b1d2c97-5d37-89d6-e063-6394a90a4402
- 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
N468001061133followed by a unit qualifier and the quantityPackage 68001-0611-33. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 68001-611
- What is NDC 68001-611?
- 68001-611 is the product NDC for Zoledronic acid, Zoledronic acid 5 mg/100mL injection, listed with the FDA by BluePoint Laboratories. 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?
- BluePoint Laboratories, NDC labeler code 68001. 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 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 |
| Zoledronic Acid | Zoledronic acid 5 mg/100mL | Injection, SolutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-806 | 71288-0806-51 |
Other NDCs under ANDA 209578
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 5 mg/100mL | InjectionIntravenous | Gland Pharma Limited | 68083-256 |
| Zoledronic acid | Zoledronic acid 5 mg/100mL | InjectionIntravenous | FOSUN PHARMA USA INC | 72266-152 |