Zoledronic Acid
- Product NDC
- 54288-183
- 11-digit product format
- 542880183
- Labeler code
- 54288
- Product ID
- 54288-183_1e2ee6a1-6ba6-463c-a6e5-0826e9978bde
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zoledronic acid
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- BPI Labs LLC
- Application
- ANDA202930
- Marketing category
- ANDA
- Marketing start
- 2025-06-05
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zoledronic Acid
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZOLEDRONIC ACID | 4 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6XC1PAD3KF |
| Rxcui | 351114 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54288-183-01 | Zoledronic Acid | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 2 |
| 54288-183-01 | Zoledronic Acid | 5 mL in 1 VIAL, GLASS | INJECTION, SOLUTION, CONCENTRATE | 5 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 54288-183-01 | 54288018301 | 1 VIAL, GLASS in 1 CARTON (54288-183-01) / 5 mL in 1 VIAL, GLASS | 2025-06-05 | No | No | Historical |