Zoledronic Acid
- Product NDC
- 68083-615
- 11-digit product format
- 680830615
- Labeler code
- 68083
- Product ID
- 68083-615_c08f4eee-1566-4493-83f7-48fa1319a234
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zoledronic acid
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA202930
- Marketing category
- ANDA
- Marketing start
- 2023-11-08
- Substance
- ZOLEDRONIC ACID
- Active strength
- 4 mg/5mL
- Pharmacologic classes
- Bisphosphonate [EPC], Diphosphonates [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 6XC1PAD3KF | ZOLEDRONIC ACID | 165800-06-6 | ZOLEDRONIC ACID |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-615-01 | 68083061501 | 1 VIAL, GLASS in 1 CARTON (68083-615-01) / 5 mL in 1 VIAL, GLASS | 2023-11-08 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Zoledronic Acid | Gland Pharma Limited | 2023-11-15 | Human Prescription Drug Label | 21 |