Zoledronic Acid
- Product NDC
- 54288-100
- 11-digit product format
- 542880100
- Labeler code
- 54288
- Product ID
- 54288-100_fd8bf083-6f6b-44db-bc6d-5368522b83d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zoledronic acid
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- BPI Labs LLC
- Application
- ANDA207341
- Marketing category
- ANDA
- Marketing start
- 2018-04-02
- 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 |
|---|
| 54288-100-01 | Zoledronic Acid | 5 mL in 1 VIAL | INJECTION, SOLUTION, CONCENTRATE | 5 | | 14 |
| 54288-100-01 | Zoledronic Acid | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54288-100 | ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [BPI LABS, LLC] | 13 | Current NDC, Legacy NDC, 2 package rows | 20250213_634e9d4b-e940-4743-ad39-794dad28d79b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54288-100-01 | 54288010001 | 1 VIAL in 1 CARTON (54288-100-01) / 5 mL in 1 VIAL | 1 vial | 2018-04-02 | 0000-00-00 | No | No | Current |